GEN1046 Safety Trial in Patients With Malignant Solid Tumors
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT03917381
- Run by
- Genmab
- People needed
- 429
- Starts
- 2019-05-14
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Yale University Cancer Center — New Haven, Connecticut, United States
- Mayo Clinic — Jacksonville, Florida, United States
- Emory University — Atlanta, Georgia, United States
- University of Iowa Hospitals — Iowa City, Iowa, United States
- Norton Healthcare Inc — Louisville, Kentucky, United States
- University of Michigan — Ann Arbor, Michigan, United States
- START Midwest — Grand Rapids, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- NYU Langone — New York, New York, United States
- UNC Chapel Hill — Chapel Hill, North Carolina, United States
- Levine Cancer Institute, Atrium Health — Charlotte, North Carolina, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Fakultni nemocnice Brno — Brno, Czechia
- University Hospital Brno — Brno, Czechia
- Nemocnice AGEL Ostrava-Vítkovice a.s. — Nový Jičín, Czechia
- Fakultni nemocnice Olomouc — Olomouc, Czechia
- High Technology Hospital Medcenter — Batumi, Georgia
- LLC "TIM - Tbilisi Institute of Medicine" — Tbilisi, Georgia
- LTD Consilium Medulla — Tbilisi, Georgia
- Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd — Tbilisi, Georgia
- Onkologiai Klinika — Debrecen, Hungary
- BKMK Hospital — Kecskemét, Hungary
- Pulmonology Hospital Törökbálinti — Törökbálint, Hungary
- Mayo Clinic — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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