Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343613
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 9, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE November 17, 2017
Estimated Primary Completion Date June 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2017)
Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]
Number of participants with DLTs
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03343613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2017)
  • Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916 [ Time Frame: Predose Lead in Day 1 through Cycle 3 Day 1 ]
    PK: Cmax of LY3381916
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 12 Months) ]
    TTR
  • 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
  • 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
  • Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months) ]
    PFS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Non Small Cell Lung Cancer
  • Renal Cell Carcinoma
  • Triple Negative Breast Cancer
Intervention  ICMJE
  • Drug: LY3381916
    IDO-1 inhibitor administered orally
  • Drug: LY3300054
    PD-L1 inhibitor administered IV
Study Arms  ICMJE
  • Experimental: LY3381916 Escalation
    LY3381916 administered orally.
    Intervention: Drug: LY3381916
  • Experimental: LY3381916 + LY3300054 Escalation
    LY3381916 administered orally and LY3300054 administered intravenously (IV).
    Interventions:
    • Drug: LY3381916
    • Drug: LY3300054
  • Experimental: LY3381916 Expansion
    LY3381916 administered orally.
    Intervention: Drug: LY3381916
  • Experimental: LY3381916 + LY3300054 Expansion B1

    Metastatic triple negative breast cancer (TNBC)

    LY3381916 administered orally and LY3300054 administered IV.

    Interventions:
    • Drug: LY3381916
    • Drug: LY3300054
  • Experimental: LY3381916 + LY3300054 Expansion B2

    Metastatic non-small cell lung cancer (NSCLC)

    LY3381916 administered orally and LY3300054 administered IV.

    Interventions:
    • Drug: LY3381916
    • Drug: LY3300054
  • Experimental: LY3381916 + LY3300054 Expansion B3

    Metastatic clear cell carcinoma renal cell carcinoma (RCC)

    LY3381916 administered orally and LY3300054 administered IV.

    Interventions:
    • Drug: LY3381916
    • Drug: LY3300054
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2019)
175
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2017)
290
Estimated Study Completion Date  ICMJE February 18, 2022
Estimated Primary Completion Date June 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Belgium,   Denmark,   France,   Italy,   Spain,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03343613
Other Study ID Numbers  ICMJE 16786
I9L-MC-JZCA ( Other Identifier: Eli Lilly and Company )
2017-002693-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP