A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy
Stopped early · Phase 1/Phase 2
Conditions studied: Solid Tumor, Adult
In brief
The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity. Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1053 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1053. GEN1053 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1053. The study consists of two parts: Part 1 tests increasing doses of GEN1053 ("escalation"), followed by Part 2 which tests the recommended phase 2 dose GEN1053 dose from Part 1 ("expansion").
Key facts
- Study ID
- NCT05435339
- Run by
- Genmab
- People needed
- 31
- Starts
- 2022-10-04
- Expected to finish
- 2024-05-24
- Last updated by the study team
- 2025-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Yale University — New Haven, Connecticut, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Clinica Universidad de Navarra — Pamplona, Navarre, Spain
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
- Centro Integral Oncologico Clara Campal — Madrid, Spain
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.