drugset / Trial / NCT06046274

GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer

NCT06046274

Phase 2 Withdrawn Genmab BioNTech SE · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical study is to learn about the bispecific antibody, acasunlimab (also known as GEN1046) in combination with the cancer drug pembrolizumab for treatment of participants with incurable endometrial cancer (cancer of the womb). The main questions the study aims to answer are: * How well acasunlimab in combination with pembrolizumab works against endometrial cancer * What are the potential side effects participants may experience when they are treated with acasunlimab in combination with pembrolizumab Participants will receive both acasunlimab and pembrolizumab. All participants will receive active drug; no one will receive placebo. participants will participate in 1 of 2 cohorts. A participant will receive study treatment up to a maximum of 24 months. The study duration (including screening, treatment, and follow-up) for each participant will be about 39 months.

Timeline

Start
2023-10-01
Primary completion
2028-04-01
Completion
2028-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Acasunlimab Monoclonal antibody Intravenous
Subject Pembrolizumab Monoclonal antibody Intravenous

Indications