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Trial eligibility change
| eligibility_criteria | Inclusion Criteria: * Diagnosis of an advanced or unresectable malignant high grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC), fallopian tube or primary peritoneal cancer by histology (World Health Organization \[WHO\] criteria). * Participants must be considered platinum resistant or platinum ineligible. Platinum resistant disease is defined as radiographic progression within 6 months (up to 182 days) after the last dose of the most recent platinum therapy). * Prior anticancer therapy: * Must have received appropriate standard of care therapy and be appropriate for participation in a Phase I study in the opinion of the investigator. * Platinum-resistant, high grade serous EOC cannot have had more than 2 prior lines of therapy, since the development of platinum resistance or ineligibility. * For participants enrolled in backfill, subjects must provide consent to paired biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion. Exclusion Criteria: * Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, clear cell, mucinous, or borderline ovarian tumor. * Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor. * Prior history of Grade \>= 2 ILD or pneumonitis. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on Screening chest computed tomography (CT) scan. * Must not have systemically used known strong cytochrome P450 (CYP)3A inhibitors or inducers within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of the study drug through the end of the DLT observation period. If clinically indicated, strong CYP3A inhibitors and inducers may be used with caution after the dose-limiting toxicity (DLT) period. | → | Inclusion Criteria: * Diagnosis of an advanced or unresectable malignant high grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC), fallopian tube or primary peritoneal cancer by histology (World Health Organization \[WHO\] criteria). * Participants enrolled in backfill (Part 1) must provide consent to paired fresh biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion. For Parts 1-4: \- Participants must be considered platinum resistant or platinum ineligible. Platinum resistant disease is defined as radiographic progression within 6 months (up to 182 days) after the last dose of the most recent platinum therapy). For Parts 5-6: \- Participants will have platinum-sensitive disease defined as radiographic progression \> 6 months from last dose of platinum-based chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. Exclusion Criteria: * Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, mucinous, carcinosarcoma or sarcomatous histology, mixed tumors or low grade/borderline ovarian tumor. * Participants with platinum refractory disease. * Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor. * Prior history of Grade \>= 2 interstitial lung disease (ILD) or pneumonitis. * Prior history of Grade 2 \>= 2 ILD or pneumonitis or any evidence of active ILD or pneumonitis on Screening chest computed tomography (CT) scan. For Parts 3-6: * History of Grade 3/4 adverse events that, in the opinion of the investigator, are attributed to bevacizumab. * History of clinically significant cardiac disease including CHF Class II or higher NYHA; active coronary artery disease, MI within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers or digoxin are permitted). * Echocardiogram with ejection fraction \<= 50% and no other clinically significant cardiac abnormalities that in the opinion of the investigator, would increase the participants susceptibility to cardiac toxicity. For Parts 5-6: \- Participants who had prior allergic reaction to platinum containing compound. |
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