Ovarian Cancer Clinical Trial
REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1
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.
This is a multicenter, international, open-label, 2-part Phase 2 study designed to assess the efficacy and safety of luveltamab tazevibulin in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1. Part 1 will consist of 2 dosing cohorts (Cohort A and Cohort B), with subjects randomized 1:1. Part 1 will be used to optimize the dosing regimen.
Part 2 will further evaluate the efficacy and safety of the selected dosing regimen.
Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion time every 3 weeks.
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
Must have received prior bevacizumab for treatment of ovarian cancer or have a documented contraindication to receive bevacizumab
At least 1 measurable target lesion per RECIST v1.1
Adequate organ function
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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