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Spots Global Cancer Trial Database for 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.

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Bayer Study Director

Affiliation: Bayer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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