NCT03343613

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2017

Typical duration for phase_1

Geographic Reach
6 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 17, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2.2 years

First QC Date

November 9, 2017

Last Update Submit

June 8, 2020

Conditions

Solid TumorNon Small Cell Lung CancerRenal Cell CarcinomaTriple Negative Breast Cancer

Keywords

IDO-1 InhibitorIDO1 InhibitorIDO Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Dose Limiting Toxicities (DLTs)

    Number of participants with DLTs

    Baseline through Cycle 1 (28 Day Cycle)

Secondary Outcomes (11)

  • Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916

    Predose Lead in Day 1 through Cycle 3 Day 1

  • PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916

    Predose Lead in Day 1 through Cycle 3 Day 1

  • PK: Cmax of LY3381916 Administered in Combination with LY3300054

    Predose Cycle 1 Day 1 through Cycle 3 Day 1

  • PK: AUC of LY3381916 Administered in Combination with LY3300054

    Predose Cycle 1 Day 1 through Cycle 3 Day 1

  • PK: Cmax of LY3300054 Administered in Combination with LY3381916

    Predose Cycle 1 Day 1 through Cycle 3 Day 1

  • +6 more secondary outcomes

Study Arms (6)

LY3381916 Escalation

EXPERIMENTAL

LY3381916 administered orally.

Drug: LY3381916

LY3381916 + LY3300054 Escalation

EXPERIMENTAL

LY3381916 administered orally and LY3300054 administered intravenously (IV).

Drug: LY3381916Drug: LY3300054

LY3381916 Expansion

EXPERIMENTAL

LY3381916 administered orally.

Drug: LY3381916

LY3381916 + LY3300054 Expansion B1

EXPERIMENTAL

Metastatic triple negative breast cancer (TNBC) LY3381916 administered orally and LY3300054 administered IV.

Drug: LY3381916Drug: LY3300054

LY3381916 + LY3300054 Expansion B2

EXPERIMENTAL

Metastatic non-small cell lung cancer (NSCLC) LY3381916 administered orally and LY3300054 administered IV.

Drug: LY3381916Drug: LY3300054

LY3381916 + LY3300054 Expansion B3

EXPERIMENTAL

Metastatic clear cell carcinoma renal cell carcinoma (RCC) LY3381916 administered orally and LY3300054 administered IV.

Drug: LY3381916Drug: LY3300054

Interventions

LY3381916DRUG

IDO-1 inhibitor administered orally

LY3381916 + LY3300054 EscalationLY3381916 + LY3300054 Expansion B1LY3381916 + LY3300054 Expansion B2LY3381916 + LY3300054 Expansion B3LY3381916 EscalationLY3381916 Expansion
LY3300054DRUG

PD-L1 inhibitor administered IV

LY3381916 + LY3300054 EscalationLY3381916 + LY3300054 Expansion B1LY3381916 + LY3300054 Expansion B2LY3381916 + LY3300054 Expansion B3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

IU Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, 37203, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Finsen Institute

Copenhagen, 2100, Denmark

Location

Gustave Roussy

Villejuif, 94805, France

Location

Azienda Ospedaliera San Gerardo

Monza, Milano, 20052, Italy

Location

Azienda Ospedaliera Umberto I

Ancona, 60100, Italy

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Andalusia, 29010, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma, Renal CellTriple Negative Breast Neoplasms

Interventions

IDO-1 inhibitor LY3381916LY3300054

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesBreast NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 17, 2017

Study Start

November 17, 2017

Primary Completion

February 7, 2020

Study Completion

May 4, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations

IT(2)ES(2)BE(3)DK(1)US(3)FR(1)