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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06046274
Study type Interventional
Source Genmab
Contact
Status Withdrawn
Phase Phase 2
Start date October 1, 2023
Completion date June 1, 2028

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