drugset / Trial / NCT04937153

GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies

NCT04937153

Phase 1 Completed 18 enrolled Genmab
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and pharmacokinetics (PK) of acasunlimab (also known as GEN1046) administered as monotherapy or in combination with pembrolizumab in Japanese study participants with malignant solid tumors.

Timeline

Start
2021-06-15
Primary completion
2024-10-01
Completion
2024-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Acasunlimab Monoclonal antibody 15 mg Intravenous
Subject Pembrolizumab Monoclonal antibody Intravenous

Indications