Summary
This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion
first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK,
pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination
with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors;
squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI)
malignancies have been selected as indications of interest for this study. Participants with
CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to
immunotherapy.