Ovarian Cancer Clinical Trial
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
Summary
A Phase 2 study to investigate the efficacy and safety of luveltamab tazevibulin in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.
Full Description
This is a randomized, multicenter, international, open-label, 2-part, Phase 2/3 study designed to assess the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1.
Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts (Cohort A and Cohort B), with subjects randomized 1:1. Part 1 will be used to select the optimized dosing regimen.
Part 2 will further evaluate the efficacy and safety of the selected dosing regimen versus IC chemotherapy.
Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion time every 3 weeks.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 38 Locations for this study
Tucson Arizona, 85711, United States More Info
Principal Investigator
Daly City California, 94015, United States More Info
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Washington District of Columbia, 20010, United States More Info
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Miami Florida, 33176, United States More Info
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Tampa Florida, 33612, United States More Info
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Baltimore Maryland, 21215, United States More Info
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Worcester Massachusetts, 01655, United States More Info
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Minneapolis Minnesota, 55404, United States More Info
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Omaha Nebraska, 68114, United States More Info
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Albuquerque New Mexico, 87109, United States More Info
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New York New York, 10016, United States More Info
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West Islip New York, 11795, United States More Info
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Cincinnati Ohio, 45219, United States More Info
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Columbus Ohio, 43210, United States More Info
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Kettering Ohio, 45429, United States More Info
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Tulsa Oklahoma, 74146, United States More Info
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Eugene Oregon, 97401, United States More Info
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Portland Oregon, 97213, United States More Info
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Lancaster Pennsylvania, 17602, United States More Info
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Philadelphia Pennsylvania, 19107, United States More Info
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Dallas Texas, 75231, United States More Info
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Dallas Texas, 75246, United States More Info
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San Antonio Texas, 78240, United States More Info
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The Woodlands Texas, 77380, United States More Info
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Fairfax Virginia, 22031, United States More Info
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Camperdown New South Wales, 2050, Australia More Info
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Randwick New South Wales, 2031, Australia More Info
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Montréal Quebec, H4A 3, Canada More Info
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Toronto , M5G 1, Canada More Info
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Seongnam-si Gyeonggi-do, 13620, Korea, Republic of More Info
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Daegu , 42061, Korea, Republic of More Info
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Gyeonggi-do , 10408, Korea, Republic of More Info
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Incheon , 21565, Korea, Republic of More Info
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Seoul , 03722, Korea, Republic of More Info
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Novena , 32956, Singapore More Info
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Singapore , 16858, Singapore More Info
Principal Investigator
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