This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
710
INCB161734 will be administered at protocol defined dose.
Cetuximab will be administered at protocol defined dose.
Retifanlimab will be administered at protocol defined dose.
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 monotherapy and in combination with cetuximab and retifanlimab.
Time frame: Up to 2 years and 90 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 2 years and 90 days
INCB161734 pharmacokinetic (PK) in Plasma
INCB161734 concentration in plasma.
Time frame: Up to approximately 90 days
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 2 years
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 2 years
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GEMNabP will be administered at protocol defined dose.
mFOLFIRINOX will be administered at protocol defined dose.
FOLFOX will be administered at protocol defined dose.
FOLFIRI will be administered at protocol defined dose.
INCA33890 will be administered at protocol defined dose.
Mayo Clinic Hospital
Phoenix, Arizona, United States
RECRUITINGStanford University
Palo Alto, California, United States
RECRUITINGUCLA Healthcare Hematology-Oncology
Santa Monica, California, United States
RECRUITINGSarah Cannon Research Institue At Healthone
Denver, Colorado, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGSidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGHackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGWeill Cornell Medicine
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITING...and 24 more locations
Time frame: Up to 2 years