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

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-002 given intravenously every 3 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sutro Biopharma, Inc.
• Treatments: Antibodies; Folic Acid Antagonists

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Measurable disease per RECIST 1.1

3. ECOG performance status (0-1)

4. Life expectancy > 3 months

5. Pathological confirmation of disease under study (historical information, diagnosis, pathology report, etc)

1. Expansion Cohort A: High-grade serous EOC, fallopian tube cancer or primary peritoneal cancer

2. Expansion Cohort B: Histologically diagnosed epithelial endometrial cancer (endometrioid and serous adenocarcinomas; undifferentiated carcinoma; mixed epithelial carcinoma; or adenocarcinoma NOS)

6. Relapsed and/or progressive disease

1. Dose Expansion Cohort A (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.

2. 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.

7. Fresh or archival tumor tissue samples

Exclusion Criteria:

1. Low grade (grade 1) ovarian carcinoma, clear cell, mucinous and sarcomatous ovarian carcinomas (Cohort A).

2. Endometrial carcinosarcomas, leiomyosarcoma and stromal sarcomas (Cohort B).

3. Prior treatment with a FolRα-targeting ADCs or FolRα-targeting vaccines

4. Platinum-refractory during frontline treatment (Cohort A)

5. Greater than 3 lines of prior treatment

6. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment

7. 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

8. Metastatic central nervous system or meningeal disease

9. Concurrent participation in another therapeutic treatment trial