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

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLY3381916 and LY3300054

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 9, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Eli Lilly and Company
Interventions being studied: Drug: LY3381916; Drug: LY3300054

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Biomarkers

PD-L1→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

IU Simon Cancer CenterIndianapolis, Indiana
Sarah Cannon Research Institute SCRINashville, Tennessee
Tennessee Oncology PLLCNashville, Tennessee
Institut Jules BordetBrussels
Universitair Ziekenhuis AntwerpenEdegem
Universitair Ziekenhuis GentGhent
Finsen InstituteCopenhagen
Gustave RoussyVillejuif
Azienda Ospedaliera San GerardoMonza, Milano
Azienda Ospedaliera Umberto IAncona
Hospital Clinico Universitario Virgen de la VictoriaMálaga, Andalusia
Hospital Universitari Vall d'HebronBarcelona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 9, 2020. Always confirm current availability with the study team.

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