Phase
Condition
Ovarian Cancer
Endometriosis
Ovarian Cysts
Treatment
STRO-002
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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 orprimary peritoneal cancer
Expansion Cohort B: Histologically diagnosed epithelial endometrial cancer (endometrioid and serous adenocarcinomas; undifferentiated carcinoma; mixedepithelial 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 platinumstatus)and received 2-3 prior regimens or
- Progressed after 1 line of platinum therapy and 1 line of non-platinumtherapy and received a total of 2-3 prior regimens if contraindicated toreceive second platinum regimen.
- Dose Expansion Cohort B (Endometrial Cancer):
- Relapsed or progression after at least 1 platinum-based chemotherapyregimen or 1 immunotherapy-based regimen but not to exceed more than 3prior regimens.
- Fresh or archival tumor tissue samples
Exclusion
Exclusion Criteria:
Low grade (grade 1) ovarian carcinoma, clear cell, mucinous and sarcomatous ovariancarcinomas (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 therapyor to antibody-related fusion protein treatment
Preexisting clinically significant ocular disorders, clinically significantpre-exisiting ocular disorders, severe chronic obstructive pulmonary disease orasthma, clinically significant cardiac or cerebrovascular disease, or othersignificant concurrent, uncontrolled medical condition
Metastatic central nervous system or meningeal disease
Concurrent participation in another therapeutic treatment trial
Study Design
Study Description
Connect with a study center
Vall d'Hebron Institut d'Oncologia
Barcelona, 08035
SpainSite Not Available
Clínica Universidad de Navarra -Madrid
Madrid, 28027
SpainSite Not Available
Hospital Universitario HM Sanchinarro - CIOCC
Madrid, 28050
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Arizona Oncology - Tucson
Tucson, Arizona 85711
United StatesSite Not Available
UCLA Jonsson Comprehensive Cancer Center Clinical Research Unit
Los Angeles, California 90095
United StatesSite Not Available
Sutter Health- Palo Alto Medical Foundation
San Francisco, California 94109
United StatesSite Not Available
Rocky Mountain Cancer Center
Aurora, Colorado 80012
United StatesSite Not Available
Yale School of Medicine
New Haven, Connecticut 06520
United StatesSite Not Available
Miami Cancer Institue, Baptist Health South Florida
Miami, Florida 33176
United StatesSite Not Available
University of South Florida
Tampa, Florida 33606
United StatesSite Not Available
Augusta Oncology
Augusta, Georgia 30912
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Maryland Oncology Hematology
Rockville, Maryland 20850
United StatesSite Not Available
Minnesota Oncology Hematology
Minneapolis, Minnesota 55404
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United StatesSite Not Available
NYU Langone Medical Center
New York, New York 10016
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
University of Cincinnati Cancer Institute
Cincinnati, Ohio 45267
United StatesSite Not Available
Ohio State University, James Cancer Center
Columbus, Ohio 43210
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Prisma Health
Greenville, South Carolina 29605
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesSite Not Available
Cancer Care Northwest-South Spokane
Spokane, Washington 99204
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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