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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343613
Recruitment Status : Terminated (Study terminated due to strategic business decision by Eli Lilly and Company.)
First Posted : November 17, 2017
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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).

Condition or disease Intervention/treatment Phase
Solid Tumor Non Small Cell Lung Cancer Renal Cell Carcinoma Triple Negative Breast Cancer Drug: LY3381916 Drug: LY3300054 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : February 7, 2020
Actual Study Completion Date : May 4, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3381916 Escalation
LY3381916 administered orally.
 Drug: LY3381916
IDO-1 inhibitor administered orally
Experimental: LY3381916 + LY3300054 Escalation
LY3381916 administered orally and LY3300054 administered intravenously (IV).
 Drug: LY3381916
IDO-1 inhibitor administered orally

Drug: LY3300054
PD-L1 inhibitor administered IV
Experimental: LY3381916 Expansion
LY3381916 administered orally.
 Drug: LY3381916
IDO-1 inhibitor administered orally
Experimental: LY3381916 + LY3300054 Expansion B1

Metastatic triple negative breast cancer (TNBC)

LY3381916 administered orally and LY3300054 administered IV.

 Drug: LY3381916
IDO-1 inhibitor administered orally

Drug: LY3300054
PD-L1 inhibitor administered IV
Experimental: LY3381916 + LY3300054 Expansion B2

Metastatic non-small cell lung cancer (NSCLC)

LY3381916 administered orally and LY3300054 administered IV.

 Drug: LY3381916
IDO-1 inhibitor administered orally

Drug: LY3300054
PD-L1 inhibitor administered IV
Experimental: LY3381916 + LY3300054 Expansion B3

Metastatic clear cell carcinoma renal cell carcinoma (RCC)

LY3381916 administered orally and LY3300054 administered IV.

 Drug: LY3381916
IDO-1 inhibitor administered orally

Drug: LY3300054
PD-L1 inhibitor administered IV


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]
    Number of participants with DLTs


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916 [ Time Frame: Predose Lead in Day 1 through Cycle 3 Day 1 ]
    PK: Cmax of LY3381916

  2. PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916 [ Time Frame: Predose Lead in Day 1 through Cycle 3 Day 1 ]
    PK: AUC of LY3381916

  3. PK: Cmax of LY3381916 Administered in Combination with LY3300054 [ Time Frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1 ]
    PK: Cmax of LY3381916 administered in combination with LY3300054

  4. PK: AUC of LY3381916 Administered in Combination with LY3300054 [ Time Frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1 ]
    PK: AUC of LY3381916 administered in combination with LY3300054

  5. PK: Cmax of LY3300054 Administered in Combination with LY3381916 [ Time Frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1 ]
    PK: Cmax of LY3300054 administered in combination with LY3381916

  6. PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916 [ Time Frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1 ]
    PK: Cmin of LY3300054 administered in combination with LY3381916

  7. Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months) ]
    ORR: Percentage of participants with a CR or PR

  8. Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 12 Months) ]
    TTR

  9. Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months) ]
    DCR: Percentage of participants who exhibit SD, CR or PR

  10. Duration of Response (DOR) [ Time Frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) ]
    DOR

  11. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months) ]
    PFS


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343613


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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03343613    
Other Study ID Numbers: 16786
I9L-MC-JZCA ( Other Identifier: Eli Lilly and Company )
2017-002693-39 ( EudraCT Number )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
IDO-1 Inhibitor
IDO1 Inhibitor
IDO Inhibitor
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Triple Negative Breast Neoplasms
Neoplasms
Neoplasms by Site
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Breast Neoplasms
Breast Diseases
Skin Diseases