This study will be conducted to evaluate INCB177054 given as monotherapy or in combination with retifanlimab in participants with select advanced or metastatic solid Tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
INCB177054 will be administered at protocol defined dose.
Retifanlimab will be administered at protocol defined dose.
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Valkyrie Clinical Trials
Panorama City, California, United States
University of Florida Health Shands Hospital
Gainesville, Florida, United States
Number of participants with Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Time frame: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: Up to approximately 12 months and 45 days
Number of participants with TEAEs leading to study drug modifications
Number of participants with TEAEs leading to dose modification including interruptions, dose reductions, and discontinuation of study drug.
Time frame: Up to approximately 12 months and 45 days
Objective Response
Defined as having a best overall response of Complete Response (CR) or Partial Response (PR) by investigator assessment (all participants) per RECIST v1.1.
Time frame: Up to approximately 12 months
Duration of Response
Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression as determined by the investigator by radiographic disease assessment per RECIST v1.1 or death due to any cause if occurring sooner than progression.
Time frame: Up to approximately 12 months
Disease Control
Defined as having a best overall response of CR, PR, or Stable Disease (SD), by investigator assessment per RECIST v1.1.
Time frame: Up to approximately 12 months
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Cancer and Hematology Centers of Western Michigan-Start Midwest
Grand Rapids, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Carolina Bio Oncology
Huntersville, North Carolina, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
Upmc Cancercenter
Pittsburgh, Pennsylvania, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States