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).

View Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT03343613

Recruitment Status:

Terminated

Sponsor:

Eli Lilly and Company

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There are 11 Locations for this study

See Locations Near You

IU Simon Cancer Center
Indianapolis Indiana, 46202, United States
Sarah Cannon Research Institute SCRI
Nashville Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
Institut Jules Bordet
Brussel , 1000, Belgium
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Finsen Institute
Copenhagen , 2100, Denmark
Gustave Roussy
Villejuif Cedex , 94805, France
Azienda Ospedaliera San Gerardo
Monza Milano, 20052, Italy
Azienda Ospedaliera Umberto I
Ancona , 60100, Italy
Hospital Clinico Universitario Virgen de la Victoria
Malaga Andalucia, 29010, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT03343613

Recruitment Status:

Terminated

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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