TerminatedPhase 1NCT03343613

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

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).

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

StatusTerminated
PhasePhase 1
U.S. locations12
SponsorEli Lilly and Company
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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.

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

04
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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