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Clinical Trial Summary

The drug that will be investigated in the study is an antibody, GEN1047. Since this is the first study of GEN1047 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1047 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1047. GEN1047 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1047. The study consists of two parts: Part 1 tests increasing doses of GEN1047 ("escalation"), followed by Part 2 which tests the recommended GEN1047 dose from Part 1 ("expansion").


Clinical Trial Description

The trial is an open-label, multi-center safety trial of GEN1047. The trial consists of two parts: a dose escalation part ("escalation" - phase 1) and an expansion part ("expansion" - phase 2a). The goal of the dose escalation part is to find out if GEN1047 is safe in patients with specific solid tumors and to find the best dose. The best dose is the so-called Recommended Phase 2 Dose (RP2D). The expansion part of the trial (phase 2a) will be initiated once the RP2D has been determined from phase 1. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05180474
Study type Interventional
Source Genmab
Contact Genmab Trial Information
Phone +4570202728
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date December 13, 2021
Completion date January 31, 2025

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