NCT03666273View on ClinicalTrials.gov

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.

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 12, 2018

Primary Completion Date

June 16, 2023

Study Completion Date

May 15, 2024

Conditions
Advanced Solid TumorHead and Neck Squamous Cell Carcinoma
Interventions
DRUG

Bapotulimab (BAY1905254)

Intravenous administration of escalating doses of Bapotulimab

DRUG

Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)

Intravenous administration of Bapotulimab of fixed dose (expansion), and of a fixed dose of pembrolizumab

Trial Locations (8)

43210

Ohio State University, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

48202

Henry Ford Health System, Detroit

60637

University of Chicago Hospitals, Chicago

77030

University of Texas MD Anderson Cancer Center, Houston

85724

University of Arizona Cancer Center, Tucson

06510

Yale University School of Medicine, New Haven

Texas

"South Texas Accelerated Research Therapeutics , START San Antonio"

Sponsors

Lead Sponsor

Bayer
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Bayer

INDUSTRY

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. | Biotech Hunter | Biotech Hunter