Open
Actively Recruiting
Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers
About
Brief Summary
Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-002 given intravenously every 3 weeks.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
- Dose Expansion Cohorts A and C (Ovarian Cancer):
- 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
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
21-000751
Category
Hematology-Oncology
Oncology
Principal Investigator
Contact
Location
- UCLA Westwood