Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers

Prior treatment

• Prior treatment with a FolRα-targeting ADCs or FolRα-targeting vaccines
• Greater than 3 lines of prior treatment
• Preexisting clinically significant ocular disorders, clinically significant pre-exisiting ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
• Concurrent participation in another therapeutic treatment trial

Other illness

• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
• Metastatic central nervous system or meningeal disease

Other

• Low grade (grade 1) ovarian carcinoma, clear cell, mucinous and sarcomatous ovarian carcinomas (Cohort A).
• Endometrial carcinosarcomas, leiomyosarcoma and stromal sarcomas (Cohort B).
• Platinum-refractory during frontline treatment (Cohorts A and C)

• Age ≥ 18 years
• Measurable disease per RECIST 1.1
• ECOG performance status (0-1)
• Life expectancy \> 3 months
• Pathological confirmation of disease under study (historical information, diagnosis, pathology report, etc)
  • Expansion Cohorts A and C: High-grade serous EOC, fallopian tube cancer or primary peritoneal cancer
  • Expansion Cohort B: Histologically diagnosed epithelial endometrial cancer (endometrioid and serous adenocarcinomas; undifferentiated carcinoma; mixed epithelial carcinoma; or adenocarcinoma NOS)
• Relapsed and/or progressive disease
  • Dose Expansion Cohorts A and C (Ovarian Cancer):
  • Platinum resistant and received 1-3 prior regimens or
  • Platinum sensitive and either:
  • Progressed after 2 prior lines of platinum therapy (regardless of platinum status)and received 2-3 prior regimens or
  • Progressed after 1 line of platinum therapy and 1 line of non-platinum therapy and received a total of 2-3 prior regimens if contraindicated to receive second platinum regimen.
  • Dose Expansion Cohort B (Endometrial Cancer):
  • Relapsed or progression after at least 1 platinum-based chemotherapy regimen or 1 immunotherapy-based regimen but not to exceed more than 3 prior regimens.
• Fresh or archival tumor tissue samples