A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors

A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors

The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).

Inclusion Criteria:

• Dose escalation phase: Participant must have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic.
• Dose expansion B1: Metastatic TNBC participants who have not received prior PD-1/L1 treatment.
• Dose expansion B2: Metastatic NSCLC participants who have progressed on prior PD-L1/L1 treatment.
• Dose expansion B3: Metastatic clear cell carcinoma RCC who have progressed on prior PD-L1/L1 treatment.
• Have adequate organ function.
• Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Are able and willing to provide required, newly acquired tumor biopsies.
• Have discontinued previous treatments for cancer.
• Are able to swallow capsules.

Exclusion Criteria:

• Currently enrolled in a clinical study.
• Have known symptomatic central nervous system metastases or carcinomatous meningitis.
• Have a serious concomitant systemic disorder.
• Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
• Have a significant cardiac condition.
• Have previously received an indoleamine- 2,3-dioxygenase (IDO) inhibitor.
• Have an active autoimmune disease or currently require immunosuppression of >10 milligrams of prednisone or equivalent per day.
• Have interstitial lung disease or (noninfectious) pneumonitis, participants with a history of (noninfectious) pneumonitis that required steroids to assist with management.