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
Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring FOLR1, FolRα, FRα, folate receptor alpha, antibody drug conjugate, Luveltamab tazevibulin, STRO-002, luvelta
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 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 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
Sites / Locations
- MedStar Washington Hospital CenterRecruiting
- USF Research & InnovationRecruiting
- Optimum Clinical Research GroupRecruiting
- NYU Langone HealthRecruiting
- Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer CenterRecruiting
- Lancaster General HospitalRecruiting
- Chris O'Brien LifehouseRecruiting
- Prince of Wales HospitalRecruiting
- Westmead HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part 1: Luveltamab tazevibulin dose cohort A
Part 1: Luveltamab tazevibulin dose cohort B
5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for cycle 3 onwards
4.3 mg/kg q3w