Clinical Trial

GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Active, Not Recruiting Phase 1/2
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Summary
The goal of this trial is to learn about the antibody acasunlimab (an antibody also known as GEN1046) when it is used alone and when it is used together with standard of care treatment (docetaxel) or another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of patients with certain types of cancer. All subjects will receive active drug; no one will receive placebo. This trial has 2 parts. The purpose of the first part is to find out if acasunlimab at various doses is safe and to find out the best doses of acasunlimab to use. The purpose of the second part is to give acasunlimab to more subjects to see how well the doses of acasunlimab selected in the first part work against cancer when given alone and how well they work when given with pembrolizumab with or without chemotherapy. Trial details include: * The average trial duration for an individual subject will be about 74 weeks. * The average treatment duration for an individual subject will be about 21 weeks. * The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-08-05
minor Completion pushed: 2026-02 -> 2026-08-31 2026-04-07
Trial Details
NCT Number NCT03917381
Lead Sponsor Genmab
Conditions Solid Tumors
Enrollment 429 participants
Start Date 2019-05-14
Primary Completion 2025-04-01 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-04