The purpose of this study is to evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
INCB186748 will be administered at protocol defined dose.
Cetuximab will be administered at protocol defined dose.
GEMNabP will be administered at protocol defined dose.
UCLA Healthcare Hematology-Oncology
Santa Monica, California, United States
Sarah Cannon Research Institue At Healthone
Denver, Colorado, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 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 occurring after the first dose of study drug up to 30 days (for INCB186748 as monotherapy and in combination with GEMNabP or mFOLFIRINOX) and 60 days (for INCB186748 in combination with cetuximab) after the last dose of INCB186748.
Time frame: Up to approximately 12 months and 60 days
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Time frame: Up to approximately 12 months and 60 days
INCB186748 pharmacokinetic (PK) in Plasma
INCB186748 concentration in plasma.
Time frame: Up to approximately 12 months
Objective Response Rate (ORR)
Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
Time frame: Up to approximately 12 months
Disease Control Response (DCR)
Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
Time frame: Up to approximately 12 months
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mFOLFIRINOX will be administered at protocol defined dose.
Florida Cancer Specialists
Sarasota, Florida, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Scri Oncology Partners
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
Duration of Response (DOR)
Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression.
Time frame: Up to approximately 12 months