REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

Stopped early · Phase 2/Phase 3

Conditions studied: Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-resistant Ovarian Cancer

In brief

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.

Key facts

Study ID

NCT05870748

Run by

Sutro Biopharma, Inc.

People needed

600

Starts

2023-07-12

Expected to finish

2025-08-26

Last updated by the study team

2025-09-23

Who can join

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

You may qualify if…

• High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
• Age ≥ 18 years
• ECOG performance status 0 to 1
• Positive FOLR1 expression per central laboratory testing
• Relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens
• Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication
• At least 1 measurable target lesion per RECIST v1.1
• Adequate organ function

You may not qualify if…

• Low grade (Grade 1) ovarian carcinoma, clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas
• Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
• Primary platinum-refractory disease
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
• Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
• Previous solid organ transplantation
• History or clinical signs of meningeal or active central nervous system involvement
• Concurrent participation in another therapeutic treatment trial

Where it is running

• Sutter Health — Daly City, California, United States
• Scripps Health — San Diego, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Baptist Health South Florida (BHSF) - Miami Cancer Institute — Miami, Florida, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• USF Research & Innovation — Tampa, Florida, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler — Savannah, Georgia, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States
• Minnesota Oncology Hematology — Minneapolis, Minnesota, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Optimum Clinical Research Group — Albuquerque, New Mexico, United States
• NYU Langone Health — New York, New York, United States
• Good Samaritan Hospital Medical Center — West Islip, New York, United States
• Pitt County Memorial Hospital, Inc. ECU Medical Center — Greenville, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Miami Valley Hospital South — Centerville, Ohio, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Ohio State University Center — Columbus, Ohio, United States
• Kettering Health — Kettering, Ohio, United States
• ProMedica Flower Hospital — Sylvania, Ohio, United States
• Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center — Tulsa, Oklahoma, United States
• Arizona Oncology Associates, PC-Hope — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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