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

Primary Purpose

Solid Tumor, Non Small Cell Lung Cancer, Renal Cell Carcinoma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3381916
LY3300054
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring IDO-1 Inhibitor, IDO1 Inhibitor, IDO Inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IU Simon Cancer Center
  • Sarah Cannon Research Institute SCRI
  • Tennessee Oncology PLLC
  • Institut Jules Bordet
  • Universitair Ziekenhuis Antwerpen
  • Universitair Ziekenhuis Gent
  • Finsen Institute
  • Gustave Roussy
  • Azienda Ospedaliera San Gerardo
  • Azienda Ospedaliera Umberto I
  • Hospital Clinico Universitario Virgen de la Victoria
  • Hospital Universitari Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

LY3381916 Escalation

LY3381916 + LY3300054 Escalation

LY3381916 Expansion

LY3381916 + LY3300054 Expansion B1

LY3381916 + LY3300054 Expansion B2

LY3381916 + LY3300054 Expansion B3

Arm Description

LY3381916 administered orally.

LY3381916 administered orally and LY3300054 administered intravenously (IV).

LY3381916 administered orally.

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants with Dose Limiting Toxicities (DLTs)
Number of participants with DLTs

Secondary Outcome Measures

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916
PK: Cmax of LY3381916
PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916
PK: AUC of LY3381916
PK: Cmax of LY3381916 Administered in Combination with LY3300054
PK: Cmax of LY3381916 administered in combination with LY3300054
PK: AUC of LY3381916 Administered in Combination with LY3300054
PK: AUC of LY3381916 administered in combination with LY3300054
PK: Cmax of LY3300054 Administered in Combination with LY3381916
PK: Cmax of LY3300054 administered in combination with LY3381916
PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916
PK: Cmin of LY3300054 administered in combination with LY3381916
Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
ORR: Percentage of participants with a CR or PR
Time to Response (TTR)
TTR
Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
DCR: Percentage of participants who exhibit SD, CR or PR
Duration of Response (DOR)
DOR
Progression Free Survival (PFS)
PFS

Full Information

First Posted
November 9, 2017
Last Updated
June 8, 2020
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03343613
Brief Title
A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors
Official Title
A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to strategic business decision by Eli Lilly and Company.
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
May 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Non Small Cell Lung Cancer, Renal Cell Carcinoma, Triple Negative Breast Cancer
Keywords
IDO-1 Inhibitor, IDO1 Inhibitor, IDO Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3381916 Escalation
Arm Type
Experimental
Arm Description
LY3381916 administered orally.
Arm Title
LY3381916 + LY3300054 Escalation
Arm Type
Experimental
Arm Description
LY3381916 administered orally and LY3300054 administered intravenously (IV).
Arm Title
LY3381916 Expansion
Arm Type
Experimental
Arm Description
LY3381916 administered orally.
Arm Title
LY3381916 + LY3300054 Expansion B1
Arm Type
Experimental
Arm Description
Metastatic triple negative breast cancer (TNBC) LY3381916 administered orally and LY3300054 administered IV.
Arm Title
LY3381916 + LY3300054 Expansion B2
Arm Type
Experimental
Arm Description
Metastatic non-small cell lung cancer (NSCLC) LY3381916 administered orally and LY3300054 administered IV.
Arm Title
LY3381916 + LY3300054 Expansion B3
Arm Type
Experimental
Arm Description
Metastatic clear cell carcinoma renal cell carcinoma (RCC) LY3381916 administered orally and LY3300054 administered IV.
Intervention Type
Drug
Intervention Name(s)
LY3381916
Intervention Description
IDO-1 inhibitor administered orally
Intervention Type
Drug
Intervention Name(s)
LY3300054
Intervention Description
PD-L1 inhibitor administered IV
Primary Outcome Measure Information:
Title
Number of Participants with Dose Limiting Toxicities (DLTs)
Description
Number of participants with DLTs
Time Frame
Baseline through Cycle 1 (28 Day Cycle)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916
Description
PK: Cmax of LY3381916
Time Frame
Predose Lead in Day 1 through Cycle 3 Day 1
Title
PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916
Description
PK: AUC of LY3381916
Time Frame
Predose Lead in Day 1 through Cycle 3 Day 1
Title
PK: Cmax of LY3381916 Administered in Combination with LY3300054
Description
PK: Cmax of LY3381916 administered in combination with LY3300054
Time Frame
Predose Cycle 1 Day 1 through Cycle 3 Day 1
Title
PK: AUC of LY3381916 Administered in Combination with LY3300054
Description
PK: AUC of LY3381916 administered in combination with LY3300054
Time Frame
Predose Cycle 1 Day 1 through Cycle 3 Day 1
Title
PK: Cmax of LY3300054 Administered in Combination with LY3381916
Description
PK: Cmax of LY3300054 administered in combination with LY3381916
Time Frame
Predose Cycle 1 Day 1 through Cycle 3 Day 1
Title
PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916
Description
PK: Cmin of LY3300054 administered in combination with LY3381916
Time Frame
Predose Cycle 1 Day 1 through Cycle 3 Day 1
Title
Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
Description
ORR: Percentage of participants with a CR or PR
Time Frame
Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Title
Time to Response (TTR)
Description
TTR
Time Frame
Baseline to Date of CR or PR (Estimated up to 12 Months)
Title
Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
Description
DCR: Percentage of participants who exhibit SD, CR or PR
Time Frame
Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Title
Duration of Response (DOR)
Description
DOR
Time Frame
Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Title
Progression Free Survival (PFS)
Description
PFS
Time Frame
Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
IU Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Sarah Cannon Research Institute SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Institut Jules Bordet
City
Brussel
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Finsen Institute
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
State/Province
Milano
ZIP/Postal Code
20052
Country
Italy
Facility Name
Azienda Ospedaliera Umberto I
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://trials.lillytrialguide.com/en-US/trial/5sqQ8KzLnN79i471hIpC0c?conditionId=LcQNUbMtMWSEYwOSaGUIi
Description
A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors

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

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