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Bristol-Myers Squibb Company (BMY)

Completion date history

Slipped 30 times (13 pull-ins also on record) — 7495 cumulative days slipped

2026-08-05→2026-08-20(+15d)
2026-11-13→2026-07-30(-106d)
2026-03-13→2027-02-16(+340d)
2026-08-09→2026-08-28(+19d)
2027-06-10→2027-06-03(-7d)
2026-07-18→2026-09-28(+72d)
2027-05-26→2026-09-09(-259d)
2025-08-24→2028-07-13(+1054d)
2026-06-25→2027-06-30(+370d)
2026-08→2027-08(+365d)
2026-05-30→2027-06-30(+396d)
2026-06-30→2026-12-31(+184d)
2025-12-31→2027-12-31(+730d)
2033-12-31→2034-01-13(+13d)
2026-03-31→2026-04-23(+23d)
2027-02-01→2026-08-28(-157d)
2026-03-31→2026-02-28(-31d)
2026-12-01→2027-12-01(+365d)
2014-05→2014-05-28(+27d)
2026-09→2027-09(+365d)
2027-02→2026-10-06(-118d)
2027-01-30→2026-08-11(-172d)
2026-08-31→2026-11-02(+63d)
2026-10→2027-10(+365d)
2026-08→2026-12(+122d)
2028-04-06→2027-08-17(-233d)
2026-09-30→2026-12-31(+92d)
2028-12→2029-04(+121d)
2026-10-01→2028-10-01(+731d)
2026-01→2024-05-02(-609d)
2024-09-05→2024-10-10(+35d)
2026-09→2027-09(+365d)
2027-01-01→2028-01-01(+365d)
2025-12-31→2022-02-10(-1420d)
2026-09-30→2027-01-30(+122d)
2028-10-01→2028-09-15(-16d)
2026-04-02→2026-09-10(+161d)
2026-12-31→2027-12-31(+365d)
2026-05-15→2026-10-20(+158d)
2026-09→2026-11(+61d)
2026-03-01→2025-07-01(-243d)
2026-10-12→2026-11-12(+31d)
2027-03-18→2026-12-17(-91d)

Timeline — every real change on record

FDA2/20/1945, 6:30:00 AM
FDA approval
FDA9/29/1950, 5:30:00 AM
FDA approval
FDA6/8/1954, 5:30:00 AM
FDA approval
FDA9/16/1957, 5:30:00 AM
FDA approval
FDA6/3/1969, 5:30:00 AM
FDA approval
FDA5/27/1970, 5:30:00 AM
FDA approval
FDA3/3/1971, 5:30:00 AM
Anda approval

Relationships — real graph edges

SPONSORS→ Trial_494c596ef4f04f0abf1cef48f566289a
SPONSORS→ Trial_5728a7f742eb4adaa281084ee16f1ac5
SPONSORS→ Trial_cee3a7c626714c308062f7c5ad2db3e8
SPONSORS→ Trial_07e60ab29fc04d0482f470746850ea6c
SPONSORS→ Trial_013c2e74477f419ca57dbe7719e36c87
SPONSORS→ Trial_32aaa09f24464f188790733b1ac000b7
SPONSORS→ Trial_57c290d510464b35897f79a8ef2cc88c
SPONSORS→ Trial_9a177fba50144b8a9e711aca958c5d2d
SPONSORS→ Trial_ff0899a142f640e196f0126dffbe4e35
SPONSORS→ Trial_799a2338e2984004b44194868bac2fa8
SPONSORS→ Trial_545e02925f1847e28e9437c04608476c
SPONSORS→ Trial_ea2ed1ad722246da968eb9182b209ba1
SPONSORS→ Trial_dd55e9b21bbf4ba98bcd6c3c8289890c
SPONSORS→ Trial_5966aa0a0e3a41fab92fe2e6d493b9b3

Evidence — source documents

CTGOV9/23/2026, 5:06:40 AM

Trial eligibility change

eligibility_criteria

Inclusion Criteria \- Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk. Exclusion Criteria * Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary. * Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant. * Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Inclusion Criteria * Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045 without an adverse event (AE) that, in the opinion of the investigator, may indicate an unacceptable safety risk. * De-novo participants must have confirmed diagnosis of ASD with symptoms of irritability, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL). Exclusion Criteria * Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary. * Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, or ECG at the end of treatment visit of Study CN0120020, CN0120044 or CN00120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant. * Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms. * Other protocol-defined Inclusion/Exclusion criteria apply.

CTGOV10/1/2026, 5:06:59 AM

Trial eligibility change

eligibility_criteria

Inclusion Criteria: 1. Date of birth and sex recorded 2. Active user of VA (at least 1 primary care encounter in prior 2 years) at Nashville, Denver, Louisville, Chicago Jesse Brown, Kansas City, Salisbury or Seattle VAMC 3. Tobacco Use: Self-reported tobacco use of at least 100 cigarettes in lifetime 4. Additional Risk Factor 1. Self-reported history of military service exposure: direct contact with asbestos- containing material, agent orange, ionizing radiation or burn pit 2. Chronic obstructive pulmonary disease (COPD) defined as one of the two definitions below: 1.Forced expiratory volume during the first second/forced vital capacity (FEV1/ FVC) ratio of below 70% predicted 2.FEV1/FVC greater than 70% predicted or pulmonary function test (PFT) unavailable plus respiratory symptoms (chronic cough, sputum production, shortness of breath, chest tightness, wheezing) plus any one of the following functional abnormalities on PFTs or structural abnormalities on imaging: 1. Functional abnormalities on PFTs: I.FEV1 below the lower limit of normal II.Gas trapping defined as residual volume greater than upper limit of normal III.Hyperinflation defined as two out of three lung volumes (total lung capacity, functional residual capacity, residual volume) that are greater than the upper limit of normal IV.Reduced diffusion capacity of the lungs for carbon monoxide (DLCO) defined as DLCO lower than the lower limit of normal V.Rapid FEV1 decline defined as greater than 60ml/year or greater than or equal to 15% decline in FEV1 2. Structural abnormalities on imaging: I.Emphysema II.Air trapping/mosaicism 3. Self-reported prior history of tobacco-related cancer (oral cavity and pharynx, esophagus, stomach, colorectal, liver and intrahepatic bile duct, pancreas, larynx, lung and bronchus, cervix uteri, kidney and renal pelvis, urinary bladder, and acute non-lymphocytic leukemia) and without evidence of disease for at least 5 years based on chart review 4. Self-reported family history of primary lung cancer in a first degree relative 5.No exclusion criteria at study screening Exclusion Criteria: 1. Self-reported, family-reported or electronic health record (EHR) diagnosis of dementia via chart review or failure of 3-word recall from Mini-cog during study screening 2. Self-reported or EHR documented thoracic imaging surveillance for cancer or chronic lung disease 3. Self-reported or EHR diagnosis of severe illness on chart review defined as: 1. Hospice 2. End Stage Pulmonary disease or continuous supplemental oxygen use 3. Heart Failure with ejection fraction (EF) less than 25% 4. Transplant of any organ or bone marrow 5. Active cancer currently being treated except non-melanoma skin cancer 6. Condition that precludes lung cancer screening due to limited ability to undergo treatment as deemed by study PI 4. Pregnancy in the second or third trimester 5. Inability to give informed consent; no minors, prisoners, or incapacitated 6. Inability to complete computed tomography (CT) scan

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Inclusion Criteria: 1.Date of birth and sex recorded 2.Active user of VA (at least 1 primary care encounter in prior 2 years) at Nashville, Denver, Louisville, Chicago Jesse Brown, Kansas City, Salisbury or Seattle VAMC 3.Tobacco Use: Self-reported tobacco use of at least 100 cigarettes in lifetime 4.Additional Risk Factor 1. Self-reported history of military service exposure: direct contact with asbestos- containing material, agent orange, ionizing radiation or burn pit 2. Chronic obstructive pulmonary disease (COPD) defined as one of the two definitions below: 1. Forced expiratory volume during the first second/forced vital capacity (FEV1/ FVC) ratio of below 70% predicted 2. FEV1/FVC greater than 70% predicted or pulmonary function test (PFT) unavailable plus respiratory symptoms (chronic cough, sputum production, shortness of breath, chest tightness, wheezing) plus any one of the following functional abnormalities on PFTs or structural abnormalities on imaging: Functional abnormalities on PFTs: 1. FEV1 below the lower limit of normal 2. Gas trapping defined as residual volume greater than upper limit of normal 3. Hyperinflation defined as two out of three lung volumes (total lung capacity, functional residual capacity, residual volume) that are greater than the upper limit of normal 4. Reduced diffusion capacity of the lungs for carbon monoxide (DLCO) defined as DLCO lower than the lower limit of normal 5. Rapid FEV1 decline defined as greater than 60ml/year or greater than or equal to 15% decline in FEV1 Structural abnormalities on imaging: 1. Emphysema 2. Air trapping/mosaicism 3. Self-reported prior history of tobacco-related cancer (oral cavity and pharynx, esophagus, stomach, colorectal, liver and intrahepatic bile duct, pancreas, larynx, lung and bronchus, cervix uteri, kidney and renal pelvis, urinary bladder, and acute non-lymphocytic leukemia) and without evidence of disease for at least 5 years based on chart review 4. Self-reported family history of primary lung cancer in a first degree relative e .No exclusion criteria at study screening Exclusion Criteria: 1. Self-reported, family-reported or electronic health record (EHR) diagnosis of dementia via chart review or failure of 3-word recall from Mini-cog during study screening 2. Self-reported or electronic health record (EHR) documented thoracic imaging surveillance for cancer or chronic lung disease 3. Self-reported or EHR diagnosis of severe illness on chart review defined as: 1. Hospice 2. End Stage Pulmonary disease or continuous supplemental oxygen use 3. Heart Failure with ejection fraction (EF) less than 25% 4. Transplant of any organ or bone marrow 5. Active cancer currently being treated except non-melanoma skin cancer 6. Condition that precludes lung cancer screening due to limited ability to undergo treatment as deemed by study PI 4. Pregnancy in the second or third trimester 5. Inability to give informed consent; no minors, prisoners, or incapacitated 6. Inability to complete computed tomography (CT) scan

CTGOV10/6/2026, 5:05:09 AM

Trial eligibility change

eligibility_criteria

Key Inclusion Criteria: 1. Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, or colorectal adenocarcinoma 2. Measurable disease according to RECIST v1.1 and at least 1 additional site of disease amenable to biopsy 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Aged ≥18 years at time of signing informed consent 5. Adequate organ function Key Exclusion Criteria: 1. Previous solid organ or hematopoietic cell transplant 2. Evidence of rapid disease progression, defined as radiographic or clinical progression within 3 months of the most recent prior line of therapy 3. Known history of hepatitis B or HIV infection 4. Previous or concurrent malignancy except if curatively treated more than 3 years prior to enrollment 5. Known active central nervous system (CNS) metastases 6. Clinically significant pleural or pericardial effusion or peritoneal carcinomatosis 7. Active treatment with antiviral agents 8. History of severe hypersensitivity to fludarabine or cyclophosphamide 9. Prior therapies/treatments with oncolytic viruses or T cell derived cellular therapy

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Key Inclusion Criteria: 1. Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, colorectal adenocarcinoma, or biliary tract carcinoma 2. Measurable disease according to RECIST v1.1 and at least 1 additional site of disease amenable to biopsy 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Aged ≥18 years at time of signing informed consent 5. Adequate organ function Key Exclusion Criteria: 1. Previous solid organ or hematopoietic cell transplant 2. Evidence of rapid disease progression, defined as radiographic or clinical progression within 3 months of the most recent prior line of therapy 3. Known history of hepatitis B or HIV infection 4. Previous or concurrent malignancy except if curatively treated more than 3 years prior to enrollment 5. Known active central nervous system (CNS) metastases 6. Clinically significant pleural or pericardial effusion or peritoneal carcinomatosis 7. Active treatment with antiviral agents 8. History of severe hypersensitivity to fludarabine or cyclophosphamide 9. Prior therapies/treatments with oncolytic viruses or T cell derived cellular therapy Additional criteria apply and should be discussed with the study site.

CTGOV10/9/2026, 5:06:44 AM

Trial eligibility change

eligibility_criteria

Inclusion Criteria: * Age ≥16 years during dose escalation portion of study, patients must weigh ≥40 kg. * Age \>12 years during dose expansion portion of study, patients must weight ≥40 kg. * Diagnosis of AML per the WHO Classification of Hematolymphoid Tumors (5th Edition) with documented KMT2A rearrangement or NPM1 cytoplasmic-type (NPM1c) mutation. KMT2A-rearrangements must be confirmed by FISH or RNA-based fusion calling by a CLIA-certified laboratory. This study will only enroll KMT2A gene rearrangements in which there is a translocation between the N-terminal portion of KMT2A and a fusion partner, and will not include KMT2A partial tandem duplications (PTDs) or other structural alterations of KMT2A. NPM1c mutations must be confirmed by DNA sequencing in a CLIA-certified laboratory. Patients with myeloid sarcoma are eligible only if concurrent bone marrow involvement is present. Patients must have at least 5% bone marrow disease by morphology at the time of study entry. * Patients with NPM1 mutated AML must either be FLT3 ITD wild type or have an ITD allelic ratio of \<0.05 (i.e. not eligible for a targeted FLT3 tyrosine kinase inhibitor). * Patients must have relapsed or be refractory to at least one prior line of conventional therapy for AML or MDS-AML. * Eastern Cooperative Oncology Group (ECOG) performance status must be 0, 1, or 2; Karnofsky ≥50 for patients ≥16 years of age; and Lansky ≥50 for patients ≥12 to 16 years of age. * Participants must meet the following organ and marrow function as defined below: * Leukocytes \<25,000/mcL (hydroxyurea, leukapheresis, or single dose of cytarabine 1 g IV are permitted to meet this criterion) * AST(SGOT)/ALT(SGPT) ≤5 × institutional ULN and total bilirubin ≤ 2x institutional ULN unless related to leukemic involvement or known Gilbert's syndrome (for bilirubin). * Cardiac LVEF of ≥40%, as measured by echocardiogram or MUGA scan * Glomerular filtration rate (GFR)≥30 mL/min/1.73 m2 * The patient, a parent (if the patient is \<18 years old), or a legally authorized representative must be able to understand and provide informed consent. * Patients of childbearing potential are eligible for the study but must comply with the pregnancy prevention plan for study drugs. See Appendix B for details. * Patient's life expectancy attributed to AML must be greater than 3 months. * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Life expectancy attributed to malignancy other than AML must be greater than 24 months. Patients with concurrent malignancy who are receiving chemotherapy or whose disease is uncontrolled or progressing are not eligible. Exclusion Criteria: * AML diagnosis without KMT2A-rearrangement or NPM1-mutation. KMT2A-PTD patients and patients with KMT2A alterations other than translocations are excluded. * Active central nervous system (CNS) involvement by AML (i.e., CNS-2 or CNS-3 disease). Previously treated CNS disease or those receiving prophylactic intrathecal chemotherapy per institutional standard is allowed. * Myeloid sarcoma or extramedullary disease without bone marrow disease. * Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1 by the NCI-CTCAE version 5.0) with the exception of alopecia. * Participants who are receiving any other investigational agents for this condition. * Clinically active HIV disease. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to mezigdomide (i.e. lenalidomide, thalidomide) * Patient received chemotherapy, immunotherapy, radiation therapy, or ancillary therapy that is considered to be investigational \<7 days prior to the first dose of ziftomenib and mezigdomide, or within 5 drug half-lives prior to the first dose of study drug, whichever is longer. * Patients with psychiatric, familial, or geographic factors that may impede ability to provide informed consent, to follow study protocol, or hamper study compliance. * Any other significant medical or psychosocial comorbidities that would preclude the patient from participating in the study or would confound interpretation of study results. * Patients with the following uncontrolled comorbidities will be excluded: symptomatic congestive heart failure (NYHA class 3 or higher), unstable angina pectoris, serious cardiac arrhythmia as uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia (type 1 NSTEMI), active, uncorrected conduction abnormalities as Mobitz 2 or third degree heart block (not excluded if pacemaker placed), myocardial infarction with evidence of residual abnormalities within 6 months prior to enrollment. An elevation in troponin is not an exclusion criterion if there are no evidence of residual cardiac dysfunction or ongoing ischemic event. Patients with congenital conduction abnormalities as Wolff-Parkinson White, long QT syndrome, or Brugada syndrome may be eligible with consultation of cardiology confirming stability. * Mean corrected QT interval corrected for heart rate by Frederica's formula (QTcF)\>480ms. * Patients on dialysis. * Patients with active infection that are deemed controlled will be permitted to enroll. Patients with uncontrolled infection may enroll once infection is treated and brought under control. * Subjects who have undergone a hematopoietic stem cell transplant (HSCT) within 90 days of the first dose of treatment on study, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD), requiring an equivalent dose of ≥ 0.5mg/kg/day of prednisone or therapy beyond systemic corticosteroids. (The use of topical steroids for ongoing skin GVHD is permitted.) * Patients who are unable to swallow pills. * Patient with gastrointestinal disease or surgery (e.g., gastric bypass surgery) that may significantly alter the absorption of mezigdomide and/or other oral study treatment. * Proton pump inhibitors and potassium-competitive acid blockers are not permitted due to limited absorption of mezigdomide if the stomach is not acidic; a 7-day washout is required prior to start of study treatment. * Has active Hepatitis B or C

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Inclusion Criteria: * Age ≥16 years during dose escalation portion of study, patients must weigh ≥40 kg. * Age \>12 years during dose expansion portion of study, patients must weight ≥40 kg. * Diagnosis of AML per the WHO Classification of Hematolymphoid Tumors (5th Edition) with documented KMT2A rearrangement or NPM1 cytoplasmic-type (NPM1c) mutation. KMT2A-rearrangements must be confirmed by FISH or RNA-based fusion calling by a CLIA-certified laboratory. This study will only enroll KMT2A gene rearrangements in which there is a translocation between the N-terminal portion of KMT2A and a fusion partner, and will not include KMT2A partial tandem duplications (PTDs) or other structural alterations of KMT2A. NPM1c mutations must be confirmed by DNA sequencing in a CLIA-certified laboratory. Patients with myeloid sarcoma are eligible only if concurrent bone marrow involvement is present. Patients must have at least 5% bone marrow disease by morphology at the time of study entry. * Patients with NPM1 mutated AML must either be FLT3 ITD wild type or have an ITD allelic ratio of \<0.05 (i.e. not eligible for a targeted FLT3 tyrosine kinase inhibitor). * Patients must have relapsed or be refractory to at least one prior line of conventional therapy for AML or MDS-AML. * Eastern Cooperative Oncology Group (ECOG) performance status must be 0, 1, or 2; Karnofsky ≥50 for patients ≥16 years of age; and Lansky ≥50 for patients ≥12 to 16 years of age. * Participants must meet the following organ and marrow function as defined below: * Leukocytes \<25,000/mcL (hydroxyurea, leukapheresis, or single dose of cytarabine 1 g IV are permitted to meet this criterion) * AST(SGOT)/ALT(SGPT) ≤5 × institutional ULN and total bilirubin ≤ 2x institutional ULN unless related to leukemic involvement or known Gilbert's syndrome (for bilirubin). * Cardiac LVEF of ≥40%, as measured by echocardiogram or MUGA scan * Glomerular filtration rate (GFR)≥30 mL/min/1.73 m2 * The patient, a parent (if the patient is \<18 years old), or a legally authorized representative must be able to understand and provide informed consent. * Patients of childbearing potential are eligible for the study but must comply with the pregnancy prevention plan for study drugs. See Appendix B for details. * Patient's life expectancy attributed to AML must be greater than 3 months. * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Life expectancy attributed to malignancy other than AML must be greater than 24 months. Patients with concurrent malignancy who are receiving chemotherapy or whose disease is uncontrolled or progressing are not eligible. Exclusion Criteria: * AML diagnosis without KMT2A-rearrangement or NPM1-mutation. KMT2A-PTD patients and patients with KMT2A alterations other than translocations are excluded. * Active central nervous system (CNS) involvement by AML (i.e., CNS-2 or CNS-3 disease). Previously treated CNS disease or those receiving prophylactic intrathecal chemotherapy per institutional standard is allowed. * Myeloid sarcoma or extramedullary disease without bone marrow disease. * Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1 by the NCI-CTCAE version 6.0) with the exception of alopecia. * Participants who are receiving any other investigational agents for this condition. * Clinically active HIV disease. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to mezigdomide (i.e. lenalidomide, thalidomide) * Patient received chemotherapy, immunotherapy, radiation therapy, or ancillary therapy that is considered to be investigational \<7 days prior to the first dose of ziftomenib and mezigdomide, or within 5 drug half-lives prior to the first dose of study drug, whichever is longer. * Patients with psychiatric, familial, or geographic factors that may impede ability to provide informed consent, to follow study protocol, or hamper study compliance. * Any other significant medical or psychosocial comorbidities that would preclude the patient from participating in the study or would confound interpretation of study results. * Patients with the following uncontrolled comorbidities will be excluded: symptomatic congestive heart failure (NYHA class 3 or higher), unstable angina pectoris, serious cardiac arrhythmia as uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia (type 1 NSTEMI), active, uncorrected conduction abnormalities as Mobitz 2 or third degree heart block (not excluded if pacemaker placed), myocardial infarction with evidence of residual abnormalities within 6 months prior to enrollment. An elevation in troponin is not an exclusion criterion if there are no evidence of residual cardiac dysfunction or ongoing ischemic event. Patients with congenital conduction abnormalities as Wolff-Parkinson White, long QT syndrome, or Brugada syndrome may be eligible with consultation of cardiology confirming stability. * Mean corrected QT interval corrected for heart rate by Frederica's formula (QTcF)\>480ms. * Patients on dialysis. * Patients with active infection that are deemed controlled will be permitted to enroll. Patients with uncontrolled infection may enroll once infection is treated and brought under control. * Subjects who have undergone a hematopoietic stem cell transplant (HSCT) within 90 days of the first dose of treatment on study, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD), requiring an equivalent dose of ≥ 0.5mg/kg/day of prednisone or therapy beyond systemic corticosteroids. (The use of topical steroids for ongoing skin GVHD is permitted.) * Patients who are unable to swallow pills. * Patient with gastrointestinal disease or surgery (e.g., gastric bypass surgery) that may significantly alter the absorption of mezigdomide and/or other oral study treatment. * Proton pump inhibitors and potassium-competitive acid blockers are not permitted due to limited absorption of mezigdomide if the stomach is not acidic; a 7-day washout is required prior to start of study treatment. * Has active Hepatitis B or C

CTGOV10/22/2026, 5:05:20 AM

Trial eligibility change

eligibility_criteria

Inclusion Criteria: * All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant. * Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF. Exclusion Criteria: * History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures. * Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Inclusion Criteria * All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant. * Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF. Exclusion Criteria * History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures. * Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator. * For participants in Part 1B1, 1B2, 2B1 and 2B2: active autoimmune disease or requirement for systemic immunosuppressive therapy. * For participants in Part 1B1, 1B2, 2B1 and 2B2: History of interstitial lung disease or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis. * For participants in Part 1B1, 1B2, 2B1 and 2B2: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding. * Other protocol-defined Inclusion/Exclusion criteria apply.

CTGOV10/29/2026, 5:04:48 AM

Trial eligibility change

eligibility_criteria

Key Inclusion Criteria: * Adults, aged 18-75 years inclusive at the time of giving informed consent. Local laws will be followed if the age at consent is older. * Have a histologically confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype consistent with WHO CNS 2021 criteria. * Have recurrent supratentorial GBM who have received prior treatment with at least radiotherapy and temozolomide. * Have first recurrence documented by magnetic resonance imaging (MRI), with an interval of at least 12 weeks after the end of prior radiotherapy unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field. * Have been clinically evaluated as having relapsed or progressed disease with at least one measurable lesion as the targeted lesion based on RANO 2.0 criteria. * Have KPS ≥60. * Can swallow the medication and maintain oral administration. * Have a baseline brain MRI, not more than 14 days before starting the study treatment. * Have a stable dose of steroids ≥7 days before the contrast-enhanced scan. * Have adequate organ function, as defined in the protocol. Key Exclusion Criteria: * Have received any of the following therapies or drugs before study enrollment: * Any anticancer therapies, including systemic, palliative, biologic, immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting the study treatment. * PD(L)-1/VEGF bispecific antibodies, cluster of differentiation (CD)137 agonists or other immune checkpoint blockade therapies including monotherapy with either category or combinations thereof. * Systemic corticosteroids (at a dosage greater than 2 mg/day of dexamethasone or an equivalent dose of other corticosteroids) within 7 days before starting the study treatment. * Vaccinations with live attenuated vaccine(s) within 4 weeks before starting the study treatment. * Broad-spectrum intravenous antibiotics therapy within 2 weeks before starting the study treatment. * Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before starting the study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study. * Antiplatelet drugs, such as aspirin (\>325 mg/day), clopidogrel (\>75 mg/day), dipyridamole, ticlopidine or cilostazol, etc., within 10 days before starting the study treatment to avoid inclusion of participants who have used platelet aggregation inhibitors before the study. * Have had more than one recurrence of GBM. * Are allergic to dacarbazine and temozolomide. * Have known leptomeningeal disease, extracranial disease, or multicentric disease. * Have been diagnosed with secondary GBM (i.e., glioblastomas that progress from low grade diffuse astrocytoma or anaplastic astrocytoma). * Have previously received radiotherapy with anything other than standard radiotherapy (i.e., focally directed radiation). * Have received prior interstitial brachytherapy, interstitial thermal therapy, implanted chemotherapy, or therapeutics delivered by local injection or convection-enhanced drug delivery. Participants who had prior treatment with Gliadel® wafers and who had concurrent use of devices such as Tumor Treating Fields are excluded. * Have uncontrolled hypertension or poorly controlled diabetic conditions as specified in the protocol before study enrollment. * Are unable (due to existent medical condition, e.g., pacemaker or implantable cardioverter defibrillator device) or unwilling to have a head contrast-enhanced MRI. * Have undergone major surgery, open biopsy, or significant traumatic injury within 28 days before starting the study treatment, or a planned/anticipated need for major surgery during the study treatment period. Placement of vascular infusion devices is allowed. Note: If participant has had major surgery, they must have recovered adequately from the toxicity and/or complications from the treatment prior to the initiation of study treatment. * Have received allogeneic hematopoietic stem cell transplantation or organ transplantation. * Have had other malignant tumors within 5 years before starting the study treatment. Exception: those who have been cured with local treatment (such as basal cell or squamous-cell carcinoma of the skin, superficial or noninvasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of thyroid and early-stage prostate cancer). * Have any of the following heart conditions within 6 months before starting the study treatment: * Myocardial infarction, unstable angina, acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, stroke, cerebrovascular accident or other Grade 3 and above cardiovascular events. * New York Heart Association functional classification ≥II heart failure or left ventricular ejection fraction \<50%. * Ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, or congenital long QT syndrome. Participants with stable treated cardiac arrythmia/atrial fibrillation are allowed. * Mean QTcF \>480 ms (the electrocardiogram can be repeated at the discretion of the investigator). * Cardiac troponin I or T \>2 × upper limit normal. * Have serious or non-healing wounds, ulcers, or (incompletely healed) bone fracture. This includes history (within 6 months before starting the study treatment) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation. * Have significant risk of hemorrhage (in the opinion of the investigator) or evidence of major coagulation disorders. * Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). However, participants who are clinically stable following treatment for these conditions (including therapeutic thoracentesis or paracentesis or with indwelling catheters, e.g., PleurX) are allowed. * Have adverse events from prior antitumor therapy that have not returned to Grade 1 (graded by CTCAE v5.0 criteria) or below (unless the investigator determines that certain adverse events pose no safety risk to participants, such as hair loss or stable hypothyroidism under hormone replacement therapy). * Active colitis, including infectious, radioactive, ischemic enteritis, within 4 weeks before starting the study treatment. * History of serious allergic diseases, history of serious allergy to drugs (including unlisted investigational drug) or known allergy or intolerance to any ingredient of the study treatment. * Uncontrolled seizures after best medical therapy or other neurological conditions including clinically significant autoimmune neurological disorders which can increase risk for adverse effects or confound assessment of study outcomes as determined by the investigator. * Have superior vena cava syndrome or symptoms of spinal cord compression. * Have active, or a history of, pneumonitis requiring treatment with steroids, or have active or a history of interstitial lung disease. * Have a known history of tuberculosis that was not successfully treated. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

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Key Inclusion Criteria: * Adults, aged 18 to 75 years inclusive at the time of giving informed consent. Local laws will be followed in countries where adulthood is defined as older than 18 years. * Have a histologically confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype consistent with WHO CNS 2021 criteria. * Have recurrent supratentorial GBM who have received prior treatment with at least radiotherapy and temozolomide. Exception: For participants who discontinued temozolomide or switched to an alternative treatment prior to disease recurrence due to temozolomide intolerance, an interval of ≥6 months between the completion of radiotherapy and first disease recurrence is acceptable. * Have first recurrence documented by magnetic resonance imaging (MRI), with an interval of at least 12 weeks after the end of prior radiotherapy unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field. * Have been clinically evaluated as having relapsed or progressed disease with at least one measurable lesion as the targeted lesion based on RANO 2.0 criteria. * Have KPS ≥60. * Can swallow the medication and maintain oral administration. * Have a baseline brain MRI, not more than 14 days before starting the study treatment. * Have a stable dose of steroids ≥7 days before the contrast-enhanced scan. * Have adequate organ function, as defined in the protocol. Key Exclusion Criteria: * Have received any of the following therapies or drugs before study enrollment: * Any anticancer therapies, including systemic, palliative, biologic, immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting the study treatment. For bevacizumab, the washout period is 4 weeks before the first dose of study treatment. * Programmed death-1 / programmed death-ligand 1/vascular endothelial growth factor bispecific antibodies, cluster of differentiation 137 agonists or other immune checkpoint blockade therapies including monotherapy with either category or combinations thereof. * Systemic corticosteroids (at a dosage greater than 2 mg/day of dexamethasone or an equivalent dose of other corticosteroids) within 7 days before starting the study treatment. * Vaccinations with live attenuated vaccine(s) within 4 weeks before starting the study treatment. * Broad-spectrum intravenous antibiotics therapy within 2 weeks before starting the study treatment. * Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before starting the study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study. * Antiplatelet drugs, such as aspirin (\>325 mg/day), clopidogrel (\>75 mg/day), dipyridamole, ticlopidine or cilostazol, etc., within 10 days before starting the study treatment to avoid inclusion of participants who have used platelet aggregation inhibitors before the study. * Have had more than one recurrence of GBM. * Are allergic to dacarbazine and temozolomide. * Have known leptomeningeal disease, extracranial disease, or multicentric disease. * Have been diagnosed with secondary GBM (i.e., glioblastomas that progress from low grade diffuse astrocytoma or anaplastic astrocytoma). * Have previously received radiotherapy with anything other than standard radiotherapy (i.e., focally directed radiation). * Have received prior interstitial brachytherapy, interstitial thermal therapy, implanted chemotherapy, or therapeutics delivered by local injection or convection-enhanced drug delivery. Participants who had prior treatment with Gliadel® wafers and who had concurrent use of devices such as Tumor Treating Fields are excluded. * Have uncontrolled hypertension or poorly controlled diabetic conditions as specified in the protocol before study enrollment. * Are unable (due to existent medical condition, e.g., pacemaker or implantable cardioverter defibrillator device) or unwilling to have a head contrast-enhanced MRI. * Have undergone major surgery, open biopsy, or significant traumatic injury within 28 days before starting the study treatment, or a planned/anticipated need for major surgery during the study treatment period. Placement of vascular infusion devices is allowed. Note: If participant has had major surgery, they must have recovered adequately from the toxicity and/or complications from the treatment prior to the initiation of study treatment. * Have received allogeneic hematopoietic stem cell transplantation or organ transplantation. * Have had other malignant tumors within 5 years before starting the study treatment. Exception: those who have been cured with local treatment (such as basal cell or squamous-cell carcinoma of the skin, superficial or noninvasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of thyroid and early-stage prostate cancer). * Have any of the following heart conditions within 6 months before starting the study treatment: * Myocardial infarction, unstable angina, acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, stroke, cerebrovascular accident or other Grade 3 and above cardiovascular events. * New York Heart Association functional classification ≥II heart failure or left ventricular ejection fraction \<50%. * Ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, or congenital long QT syndrome. Participants with stable treated cardiac arrythmia/atrial fibrillation are allowed. * Mean QT interval corrected by Fridericia's method (QTcF) \>480 ms (the electrocardiogram can be repeated at the discretion of the investigator). * Cardiac troponin I or T \>2 × upper limit normal. * Have serious or non-healing wounds, ulcers, or (incompletely healed) bone fracture. This includes history (within 6 months before starting the study treatment) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation. * Have significant risk of hemorrhage (in the opinion of the investigator) or evidence of major coagulation disorders. * Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). However, participants who are clinically stable following treatment for these conditions (including therapeutic thoracentesis or paracentesis or with indwelling catheters, e.g., PleurX) are allowed. * Have adverse events from prior antitumor therapy that have not returned to Grade 1 (graded by CTCAE v5.0 criteria) or below (unless the investigator determines that certain adverse events pose no safety risk to participants, such as hair loss or stable hypothyroidism under hormone replacement therapy). * Active colitis, including infectious, radioactive, ischemic enteritis, within 4 weeks before starting the study treatment. * History of serious allergic diseases, history of serious allergy to drugs (including unlisted investigational drug) or known allergy or intolerance to any ingredient of the study treatment. * Uncontrolled seizures after best medical therapy or other neurological conditions including clinically significant autoimmune neurological disorders which can increase risk for adverse effects or confound assessment of study outcomes as determined by the investigator. * Have superior vena cava syndrome or symptoms of spinal cord compression. * Have active, or a history of, pneumonitis requiring treatment with steroids, or have active or a history of interstitial lung disease. * Have a known history of tuberculosis that was not successfully treated. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

CTGOV10/29/2026, 5:05:36 AM

Trial eligibility change

eligibility_criteria

Inclusion Criteria: • Technically resectable HCC as defined by: * HCC may be diagnosed pathologically, or noninvasively by the American Association for the Study of Liver Diseases (AASLD) criteria or the Organ Procurement and Transplant Network (OPTN) Obligatory Diagnostic Criteria for Hepatocellular Carcinoma (HCC). No extrahepatic spread, no nodal disease, and no bilateral left and right branch portal vein involvement. * Measurable disease per RECIST 1.1 as determined by the investigator. * Age ≥ 18 years old on the day of consent. * ECOG performance status ≤1 or Karnofsky ≥80. * Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug. * Patients must have adequate liver remnant and function. * Antiviral therapy per local standard of care for hepatitis B. * LVEF assessment with documented LVEF ≥ 50% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration. * Woman of child-bearing potential must have a negative pregnancy test. * Must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Fibrolamellar carcinoma or mixed HCC. * Receiving, or previously received, any systemic chemotherapy, or investigational agent for HCC. * Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies. * Has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy would not exclude participation in this trial. * History of HIV infection. * Active co-infection with HBV and HDV. * Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy. * Prior tissue or organ allograft or allogeneic bone marrow transplantation. * History of any autoimmune disease requiring systemic treatment within the past 2 years. * Systemic or topical corticosteroids at immunosuppressive doses (\> 10 mg/day of prednisone or equivalent). * Confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent. * Uncontrolled intercurrent illness.• * Uncontrolled or significant cardiovascular disease. * Significant heart disease. * Moderate or severe ascites. * Known or suspected hypersensitivity to study treatment. * Are pregnant or breastfeeding. * WOCBP and men with female partners (WOCBP) who are not willing to use contraception. * Unable to have blood drawn. * Any other sound medical, psychiatric, and/or social reason as determined by the Investigator. * Any illicit drugs or other substance abuse.

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Inclusion Criteria: * Technically resectable HCC as defined by: * HCC may be diagnosed pathologically, or noninvasively by the American Association for the Study of Liver Diseases (AASLD) criteria or the Organ Procurement and Transplant Network (OPTN) Obligatory Diagnostic Criteria for Hepatocellular Carcinoma (HCC). * No extrahepatic spread, no nodal disease, and no bilateral left and right branch portal vein involvement. * Measurable disease per RECIST 1.1 as determined by the investigator. * Age ≥ 18 years old on the day of consent. * ECOG performance status ≤1 or Karnofsky ≥80. * Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug. * Patients must have adequate liver remnant and function. * Antiviral therapy per local standard of care for hepatitis B. * LVEF assessment with documented LVEF ≥ 50% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration. * Woman of child-bearing potential must have a negative pregnancy test. * Must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Fibrolamellar carcinoma or mixed HCC. * Receiving, or previously received, any systemic chemotherapy, or investigational agent for HCC. * Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies. * Has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy would not exclude participation in this trial. * History of HIV infection. * Active co-infection with HBV and HDV. * Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy. * Prior tissue or organ allograft or allogeneic bone marrow transplantation. * History of any autoimmune disease requiring systemic treatment within the past 2 years. * Systemic or topical corticosteroids at immunosuppressive doses (\> 10 mg/day of prednisone or equivalent). * Confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent. * Uncontrolled intercurrent illness.• * Uncontrolled or significant cardiovascular disease. * Significant heart disease. * Moderate or severe ascites. * Known or suspected hypersensitivity to study treatment. * Are pregnant or breastfeeding. * WOCBP and men with female partners (WOCBP) who are not willing to use contraception. * Unable to have blood drawn. * Any other sound medical, psychiatric, and/or social reason as determined by the Investigator. * Any illicit drugs or other substance abuse.

CTGOV11/3/2026, 5:04:57 AM

Trial eligibility change

eligibility_criteria

Inclusion Criteria: * Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue. * Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease. * Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline. * Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN. * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor. * Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent). * Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications. * Participants must not have inadequate organ function, as determined by laboratory testing within the screening period. * Participants must not have active viral HBV or HCV hepatitis. * Other protocol defined inclusion/exclusion criteria applies.

→

Inclusion Criteria: * Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene or MTAP loss detected in tumor tissue. * Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease. * Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline and Radiologic assessment in neuro-oncology (RANO)2.0 as applicable at baseline. * Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; or ≤ 2 x ULN in subjects with liver metastasis or liver cancer. * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor. * Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent). * Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications. * Participants must not have inadequate organ function, as determined by laboratory testing within the screening period. * Participants must not have active viral HBV or HCV hepatitis. * Other protocol defined inclusion/exclusion criteria applies.

primary_outcomes	[object Object],[object Object],[object Object]	→	[object Object],[object Object],[object Object]
secondary_outcomes	[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]	→	[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

results_first_posted	null	→	2026-09-22
adverse_events_module_present	false	→	true

primary_outcomes	[object Object],[object Object]	→	[object Object],[object Object]
secondary_outcomes	[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]	→	[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

why_stopped	null	→	Inability to meet protocol objectives
overall_status	Completed	→	Terminated

why_stopped	null	→	Inability to meet protocol objectives
overall_status	Recruiting	→	Terminated

completion_date	2026-08-05	→	2026-08-20
primary_completion_date	2026-08-05	→	2026-08-20

completion_date	2026-12-31	→	2026-08-28
primary_completion_date	2026-08-09	→	2026-08-28

completion_date	2027-05-26	→	2026-09-09
primary_completion_date	2027-05-26	→	2026-09-09

completion_date	2026-12-01	→	2027-09-30
primary_completion_date	2026-06-25	→	2027-06-30

completion_date	2026-08	→	2027-08
primary_completion_date	2026-08	→	2027-08

completion_date	2026-11-30	→	2027-09-30
primary_completion_date	2026-05-30	→	2027-06-30

completion_date	2026-05-31	→	2026-11-27
primary_completion_date	2026-03-31	→	2026-04-23

completion_date	2030-09-16	→	2026-08-28
primary_completion_date	2027-02-01	→	2026-08-28

completion_date	2026-12-01	→	2027-12-01
primary_completion_date	2026-12-01	→	2027-12-01

results_first_posted	null	→	2026-10-06
adverse_events_module_present	false	→	true

completion_date	2014-05	→	2014-05-28
primary_completion_date	2014-05	→	2014-05-28

primary_outcomes	[object Object]	→	[object Object]
secondary_outcomes	[object Object]	→	[object Object],[object Object],[object Object],[object Object]

completion_date	2026-09	→	2027-09
primary_completion_date	2026-09	→	2027-09

completion_date	2027-02	→	2026-10-06
primary_completion_date	2027-02	→	2026-10-06

completion_date	2026-10-15	→	2026-11-02
primary_completion_date	2026-08-31	→	2026-11-02

completion_date	2026-10	→	2027-10
primary_completion_date	2026-10	→	2027-10

completion_date	2031-09-05	→	2031-07-14
primary_completion_date	2028-04-06	→	2027-08-17

completion_date	2026-09-30	→	2026-12-31
primary_completion_date	2026-09-30	→	2026-12-31

completion_date	2029-03	→	2029-07
primary_completion_date	2028-12	→	2029-04

results_first_posted	null	→	2026-10-14
adverse_events_module_present	false	→	true

completion_date	2026-10-01	→	2028-10-01
primary_completion_date	2026-10-01	→	2028-10-01

completion_date	2027-06-01	→	2029-06-01
primary_completion_date	2027-01-01	→	2028-01-01

completion_date	2025-12-31	→	2023-03-14
primary_completion_date	2025-12-31	→	2022-02-10

why_stopped	null	→	Study was terminated early due to toxicity concerns by the Sponsor.
overall_status	Active, not recruiting	→	Terminated

results_first_posted	null	→	2026-10-19
adverse_events_module_present	false	→	true

completion_date	2030-10-01	→	2032-03-15
primary_completion_date	2028-10-01	→	2028-09-15

completion_date	2026-12-31	→	2027-12-31
primary_completion_date	2026-12-31	→	2027-12-31

why_stopped	null	→	Business objectives have changed.
overall_status	Completed	→	Terminated

results_first_posted	null	→	2026-10-28
adverse_events_module_present	false	→	true

completion_date	2027-10-12	→	2027-11-12
primary_completion_date	2026-10-12	→	2026-11-12