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

Completed · Phase 1

Conditions studied: Ovarian Cancer, Ovarian Carcinoma, Ovary Cancer, Endometrial Cancer, Endometrioid Adenocarcinoma, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

In brief

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

Key facts

Study ID

NCT03748186

Run by

Sutro Biopharma, Inc.

People needed

136

Starts

2019-02-01

Expected to finish

2024-06-04

Last updated by the study team

2025-08-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Oncology - Tucson — Tucson, Arizona, United States
• UCLA Jonsson Comprehensive Cancer Center Clinical Research Unit — Los Angeles, California, United States
• Sutter Health- Palo Alto Medical Foundation — San Francisco, California, United States
• Rocky Mountain Cancer Center — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Miami Cancer Institue, Baptist Health South Florida — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Augusta Oncology — Augusta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Maryland Oncology Hematology — Rockville, Maryland, United States
• Minnesota Oncology Hematology — Minneapolis, Minnesota, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• NYU Langone Medical Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
• Ohio State University, James Cancer Center — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Prisma Health — Greenville, South Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Cancer Care Northwest-South Spokane — Spokane, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Vall d'Hebron Institut d'Oncologia — Barcelona, Spain
• Clínica Universidad de Navarra -Madrid — Madrid, Spain

Full record on ClinicalTrials.gov

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