A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer

Exclusion Criteria

• •1. Low grade ovarian carcinoma (Grade 1).
• •2. Clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas, endometrial leiomyosarcoma, and endometrial stromal sarcomas.
• •3. Prior treatment with an ADC with a tubulin inhibitor warhead.
• •4. Prior treatment with other FolRα targeting agents unless approved by a Sutro medical monitor or designee.
• •5. Subjects who are primary platinum-refractory during frontline treatment are excluded from the Expansion Cohort (Allowed in Dose Escalation if no more than 1 prior regimen).
• •6. Greater than 4 prior lines of treatment (\> 1 prior if primary platinum refractory).
• •7. Any prior toxicity that required permanent discontinuation of bevacizumab or other contraindication to receive bevacizumab per institutional guidelines.
• •8. Previous solid organ transplantation.
• •9. Current signs/symptoms of bowel obstruction and/or signs/symptoms of or bowel obstruction within 3 months of initiation of study treatment.
• •10. Grade ≥2 toxicity from prior anticancer therapy with the exception of Grade 2 alopecia or Grade 2 neuropathy.
• •11. Uncontrolled hypertension
• •12. Sensory or motor neuropathy Grade \> 1 at screening prior to initiation of study treatment.
• •13. Potentially fatal concurrent or recent malignancy. Subjects with past or current malignancy need to be discussed with the sponsor to determine eligibility.
• •14. Chronic or ongoing active infection requiring systemic treatment.
• •15. Ongoing immunosuppressive therapy, including systemic corticosteroids. Note: Physiologic replacement and use of topical or inhaled corticosteroids are allowed. Dexamethasone may be used to treat chemotherapy induced nausea per institutional guidelines.
• •16. Clinically significant cardiac disease.
• •17. History or clinical signs of meningeal or active central nervous system involvement.
• •18. Known severe COPD or asthma
• •19. Active pneumonitis within 6 months of initiating study treatment.
• •20. History of stroke or history of significant cerebrovascular disease (i.e., transient ischemic attack) within 6 months of initiation of study treatment.
• •21. History of pulmonary embolism or any Grade 3 thromboembolic event within 6 months of initiation of study treatment.
• •22. Known human immunodeficiency virus seropositivity.
• •23. Active hepatitis B or hepatitis C and positive serology (unless due to vaccination or passive immunization due to immunoglobulin therapy) with the following exceptions:
• •1. Subject has had HCV but received antiviral treatment and shows no detectible HCV viral DNA for 6 months prior to screening
• •2. Subject has had HBV but is HBV surface antigen (HBsAg) and viral DNA negative at screening
• •3. Subject has had HBV but received antiviral treatment and have undetectable viral DNA for 6 months prior to screening
• •24. Concurrent participation in another therapeutic treatment trial
• •25. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
• •26. Females who are pregnant or breastfeeding, and all women of childbearing potential unwilling to use adequate barrier contraception while on treatment and for 16 weeks after last dose of STRO-002/bevacizumab and 6 months after the last dose of bevacizumab.