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Brief Title: 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.
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
Study ID: NCT03666273
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona Cancer Center, Tucson, Arizona, United States
Yale University School of Medicine, New Haven, Connecticut, United States
University of Chicago Hospitals, Chicago, Illinois, United States
Henry Ford Health System, Detroit, Michigan, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics | START San Antonio, San Antonio, Texas, United States
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR