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
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
Female
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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 Cohort A: 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 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.
    • 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 (Cohort A)
  • 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
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03748186
For detailed technical eligibility, visit ClinicalTrials.gov.