A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.

• Presence of measurable disease per RECIST v1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.

• Resolution of treatment-related toxicities.

• Adequate hepatic, renal, cardiac, and hematologic function.

• Additional cohort-specific criteria may apply.

Exclusion Criteria:**

• Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
• Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
• Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
• Has received prior approved radiotherapy within 14 days of study therapy.
• Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Has an active infection requiring systemic therapy.
• Has known active CNS metastases and/or carcinomatous meningitis.
• Women who are pregnant or breastfeeding.