A clinical study to evaluate the safety, tolerability, and efficacy of INCB001158 in combination with chemotherapy in subjects with advanced or metastatic solid tumors.

Primary objectives: • Phase 1: To assess the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of INCB001158 in combination with chemotherapy.
• Phase 2: To evaluate the objective response rate (ORR) of INCB001158 in combination with chemotherapy.
Primary endpoints: • Phase 1: Safety, tolerability, dose-limiting toxicities (DLTs), and RP2D of INCB001158 in combination with chemotherapy, as assessed by adverse events (AEs), clinical laboratory tests, physical examination results, and 12-lead electrocardiogram (ECG) results.
• Phase 2: ORR, defined as the percentage of subjects having a complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per RECIST v1.1.