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

Stopped early · Phase 1

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

In brief

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).

Key facts

Study ID

NCT03343613

Run by

Eli Lilly and Company

People needed

60

Starts

2017-11-17

Expected to finish

2020-05-04

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• IU Simon Cancer Center — Indianapolis, Indiana, United States
• Sarah Cannon Research Institute SCRI — Nashville, Tennessee, United States
• Tennessee Oncology PLLC — Nashville, Tennessee, United States
• Institut Jules Bordet — Brussels, Belgium
• Universitair Ziekenhuis Antwerpen — Edegem, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Finsen Institute — Copenhagen, Denmark
• Gustave Roussy — Villejuif, France
• Azienda Ospedaliera San Gerardo — Monza, Milano, Italy
• Azienda Ospedaliera Umberto I — Ancona, Italy
• Hospital Clinico Universitario Virgen de la Victoria — Málaga, Andalusia, Spain
• Hospital Universitari Vall d'Hebron — Barcelona, Spain

Full record on ClinicalTrials.gov

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