Clinical trial details

A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-drug Conjugate, Versus Investigators Choice Chemotherapy in Women With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Identifier

CA116-001/MORAB-202-G000-205

Sponsor

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION (BMS)

Principal Investigator

ANA OAKNIN BENZAQUEN

Service

Oncology

Study details

Tumor type: GYNECOLOGICAL
Stage: Advanced
Main Investigational Agent : ADC
Phase: II
Randomization: Randomized

Molecular details

Biomarker: FRalfa pos
Biomarker criteria: Mandatory
Prescreening: Central
Additional study population requirements: Inclusion criteria: Either formalin-fixed, paraffin-embedded (FFPE) tissue (up to 5 years old) or newly-obtained biopsies must be available for FRa assessment prior to randomization.

Drug details

Arm A: Investigators Choice Chemotherapy
Arm B: MORAb-202 (Farletuzumab Ecteribulin)

Links

Clinical Trials GOV (NCT identifier): NCT05613088
EU Clinical Trials Register (eudraCT Identifier): 2021-004807-42