NCT06046274

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

A Phase 2 Exploratory, Multicenter, Open-Label Trial to Determine the Safety and Preliminary Clinical Activity of GEN1046 in Combination With Anticancer Agents in Subjects With Advanced Endometrial Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Genmab · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label multicenter study in participants with advanced (unresectable and/or metastatic) endometrial cancer to evaluate the safety and clinical activity of acasunlimab (GEN1046) in combination with immunotherapy. The trial consists of two cohorts: * Cohort A (cohort closed) * Cohort B The study will enroll approximately 80 participants in Cohort A and B (approximately 40 participants in each cohort).

Conditions

• Advanced Endometrial Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Pembrolizumab intravenous (IV) infusion
BIOLOGICAL	Acasunlimab	Acasunlimab IV infusion

Timeline

• Start date: 2023-10-01
• Primary completion: 2028-04-01
• Completion: 2028-06-01
• First posted: 2023-09-21
• Last updated: 2024-04-30

Locations

29 sites across 6 countries: United States, Belgium, Denmark, Italy, South Korea, Spain

Regulatory

• FDA-regulated drug study