Overview
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.
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
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