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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Intravenous administration of escalating doses of Bapotulimab
Intravenous administration of Bapotulimab of fixed dose (expansion), and of a fixed dose of pembrolizumab
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
Incidence of treatment-emergent AEs (TEAEs) including treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and dose-limiting toxicities (DLTs)
Time frame: Up to 58 months
Severity of treatment-emergent AEs (TEAEs) including treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and dose-limiting toxicities (DLTs)
Time frame: Up to 58 months
Cmax of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg
Maximum plasma concentration after single dose
Time frame: Up to 504 hours after drug in Cycle 1
AUC of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg
Area under the plasma concentration curve after single dose
Time frame: Up to 504 hours after drug in Cycle 1
Maximum tolerated dose (MTD) of Bapotulimab
Time frame: Up to 58 months
Recommended dose of Bapotulimab for Phase 2
Time frame: Up to 58 months
Cmax,md after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg
Maximum plasma concentration after multiple doses
Time frame: Up to 504 hours after drug in Cycle 3
AUC after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg
Area under the plasma concentration curve after multiple doses
Time frame: Up to 504 hours after drug in Cycle 3
Incidence of positive anti-drug antibody titer for Bapotulimab
Time frame: Up to 58 months
Best overall response rate
Determined by RECIST 1.1
Time frame: Up to 58 months
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