Status:
TERMINATED
A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors
Lead Sponsor:
Eli Lilly and Company
Conditions:
Solid Tumor
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03343613
Start Date
November 17 2017
End Date
May 4 2020
Last Update
June 9 2020
Active Locations (12)
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1
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
2
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States, 37203
3
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
4
Institut Jules Bordet
Brussels, Belgium, 1000