clinical 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.
Bayer·phase1·completed·n = 60
Advanced Solid TumorHead and Neck Squamous Cell CarcinomaBapotulimab (BAY1905254)Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)
brief 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.
started
Sep 12, 2018
primary completion
Jun 16, 2023
completion
May 15, 2024
last updated
May 28, 2024
official title
An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of the ILDR2 Function-blocking Antibody BAY1905254 in Patients With Advanced Solid Tumors
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol