Breast Cancer Clinical Trial
A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors
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 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.
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There are 11 Locations for this study
Indianapolis Indiana, 46202, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Brussel , 1000, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Copenhagen , 2100, Denmark
Villejuif Cedex , 94805, France
Monza Milano, 20052, Italy
Ancona , 60100, Italy
Malaga Andalucia, 29010, Spain
Barcelona , 08035, Spain
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