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

Lilly

Status and phase: Terminated; Phase 1

Conditions: Solid Tumor; Non Small Cell Lung Cancer; Triple Negative Breast Cancer; Renal Cell Carcinoma

Treatments: Drug: LY3381916; Drug: LY3300054

Study type: Interventional

Funder types: Industry

Identifiers

NCT03343613

I9L-MC-JZCA (Other Identifier)

2017-002693-39 (EudraCT Number)

16786

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 6 patient groups

LY3381916 Escalation

Experimental group

Description:

LY3381916 administered orally.

Treatment:

Drug: LY3381916

LY3381916 + LY3300054 Escalation

Experimental group

Description:

LY3381916 administered orally and LY3300054 administered intravenously (IV).

Treatment:

Drug: LY3300054

Drug: LY3381916

LY3381916 Expansion

Experimental group

Description:

LY3381916 administered orally.

Treatment:

Drug: LY3381916

LY3381916 + LY3300054 Expansion B1

Experimental group

Description:

Metastatic triple negative breast cancer (TNBC) LY3381916 administered orally and LY3300054 administered IV.

Treatment:

Drug: LY3300054

Drug: LY3381916

LY3381916 + LY3300054 Expansion B2

Experimental group

Description:

Metastatic non-small cell lung cancer (NSCLC) LY3381916 administered orally and LY3300054 administered IV.

Treatment:

Drug: LY3300054

Drug: LY3381916

LY3381916 + LY3300054 Expansion B3

Experimental group

Description:

Metastatic clear cell carcinoma renal cell carcinoma (RCC) LY3381916 administered orally and LY3300054 administered IV.

Treatment:

Drug: LY3300054

Drug: LY3381916