A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors

Inclusion Criteria:

- For Phase 1, subjects with histologically or cytologically confirmed advanced or
metastatic solid tumors that have failed prior standard therapy (disease progression;
subject intolerance is also allowable).

- For Phase 2, subjects with the following tumor types who meet protocol-defined
criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC,
and CRC.

- Presence of at least 1 measurable lesion by computed tomography or magnetic resonance
imaging per RECIST v1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

- Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy
to Grade 1 or less (except alopecia). Subjects with ≤ Grade 2 neuropathy are an
exception and may enroll.

- Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory
parameters within ≤ 7 days before treatment initiation.

Exclusion Criteria:

- Participation in any other study in which receipt of an investigational study drug or
device occurred within 2 weeks or 5 half-lives (whichever is longer) before first
dose.

- Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is
shorter) before administration of study drug.

- Prior chemotherapy or targeted small molecule therapy within 2 weeks before
administration of study treatment.

- Prior therapy with an IDO1 or arginase 1 inhibitor.

- Active autoimmune disease that has required systemic treatment in past 2 years.
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement
therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of
systemic treatment.

- Receipt of a live vaccine within 30 days before the first dose of study treatment.

- Any history of serotonin syndrome after receiving serotonergic drugs.

- Use of protocol-defined prior/concomitant therapy.

- Known or suspected defect in the function of the urea cycle.

- History of gastrointestinal condition that may affect drug absorption.