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.