drugset / Trial / NCT07637851

Safety and Efficacy of Ubamatamab With First-line Chemotherapy in Ovarian Cancer

NCT07637851

Phase 1/2 Not yet recruiting 43 enrolled ARCAGY/ GINECO GROUP Regeneron Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this clinical trial is to assess the safety and efficacy of ubamatamab in combination with first-line chemotherapy in patients with ovarian cancer. The main questions it aims to answer are: * What is the safety profile of ubamatamab when administered with carboplatin-paclitaxel ± bevacizumab? * What is the objective response rate after three cycles of ubamatamab in combination with carboplatin-paclitaxel ± bevacizumab? Participants will: * Receive three cycles of ubamatamab in combination with carboplatin-paclitaxel ± bevacizumab, followed by maintenance therapy with ubamatamab ± bevacizumab for up to 15 months, depending on HRD status and disease response after the initial treatment cycles. * Attend regular clinic visits throughout the treatment period for checkups and tests

Timeline

Start
2026-08
Primary completion
2028-09
Completion
2030-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ubamatamab Monoclonal antibody 5 mg/ml
Subject Ubamatamab Monoclonal antibody 50 mg/ml
Background Bevacizumab Monoclonal antibody
Background Carboplatin Small molecule
Background Paclitaxel Small molecule

Indications