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Study identifier: NCT03917381 Synced from ClinicalTrials.gov · August 05, 2026
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GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Condition: Solid Tumors  ·  Sponsor: Genmab

PhasePhase 1/Phase 2
Planned participants429
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (57)

Mayo ClinicPhoenix, Arizona, United States
Yale University Cancer CenterNew Haven, Connecticut, United States
Mayo ClinicJacksonville, Florida, United States
Emory UniversityAtlanta, Georgia, United States
University of Iowa HospitalsIowa City, Iowa, United States
Norton Healthcare IncLouisville, Kentucky, United States
University of MichiganAnn Arbor, Michigan, United States
START MidwestGrand Rapids, Michigan, United States
Mayo ClinicRochester, Minnesota, United States
Washington University School of MedicineSt Louis, Missouri, United States
NYU LangoneNew York, New York, United States
UNC Chapel HillChapel Hill, North Carolina, United States

+ 45 more locations — full list on the registry record.

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