drugset / Trial / NCT03666273

Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.

NCT03666273 ↗

Phase 1 Completed 60 enrolled Bayer Merck Sharp & Dohme LLC · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This study is being done to learn more about a new drug called Bapotulimab given in combination with Pembrolizumab. The purpose of this study is to learn if this new combination of drugs is safe for the participants, how it affects the body and to try to find the best dose of the new drug to give to participants and to obtain a preliminary assessment of the tumor response efficacy in the recurrent or metastatic Head and Neck Cancer.

Timeline

Start
2018-09-12
Primary completion
2023-06-16
Completion
2024-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Bapotulimab Unknown — Intravenous
Background Pembrolizumab Monoclonal antibody — Intravenous