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

• Status: Terminated
• Trial end date: 2020-05-04
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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.