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

Inclusion Criteria:

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

Exclusion Criteria:

Low grade (grade 1) ovarian carcinoma, clear cell, mucinous and sarcomatous ovarian carcinomas (Cohort A).
Endometrial carcinosarcomas, leiomyosarcoma and stromal sarcomas (Cohort B).
Prior treatment with a FolRα-targeting ADCs or FolRα-targeting vaccines
Platinum-refractory during frontline treatment (Cohorts A and C)
Greater than 3 lines of prior treatment
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein 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
Metastatic central nervous system or meningeal disease
Concurrent participation in another therapeutic treatment trial