Clinical Trials /

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

NCT03343613

Description:

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).

Related Conditions:
  • Breast Carcinoma
  • Clear Cell Renal Cell Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 16786
  • SECONDARY ID: I9L-MC-JZCA
  • SECONDARY ID: 2017-002693-39
  • NCT ID: NCT03343613

Conditions

  • Solid Tumor
  • Non Small Cell Lung Cancer
  • Renal Cell Carcinoma
  • Triple Negative Breast Cancer

Interventions

DrugSynonymsArms
LY3381916LY3381916 Escalation
LY3300054LY3381916 + LY3300054 Escalation

Purpose

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 Arms

NameTypeDescriptionInterventions
LY3381916 EscalationExperimentalLY3381916 administered orally.
  • LY3381916
LY3381916 + LY3300054 EscalationExperimentalLY3381916 administered orally and LY3300054 administered intravenously (IV).
  • LY3381916
  • LY3300054
LY3381916 ExpansionExperimentalLY3381916 administered orally.
  • LY3381916
LY3381916 + LY3300054 Expansion B1ExperimentalMetastatic triple negative breast cancer (TNBC) LY3381916 administered orally and LY3300054 administered IV.
  • LY3381916
  • LY3300054
LY3381916 + LY3300054 Expansion B2ExperimentalMetastatic non-small cell lung cancer (NSCLC) LY3381916 administered orally and LY3300054 administered IV.
  • LY3381916
  • LY3300054
LY3381916 + LY3300054 Expansion B3ExperimentalMetastatic clear cell carcinoma renal cell carcinoma (RCC) LY3381916 administered orally and LY3300054 administered IV.
  • LY3381916
  • LY3300054

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame:Baseline through Cycle 1 (28 Day Cycle)
Safety Issue:
Description:Number of participants with DLTs

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916
Time Frame:Predose Lead in Day 1 through Cycle 3 Day 1
Safety Issue:
Description:PK: Cmax of LY3381916
Measure:PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916
Time Frame:Predose Lead in Day 1 through Cycle 3 Day 1
Safety Issue:
Description:PK: AUC of LY3381916
Measure:PK: Cmax of LY3381916 Administered in Combination with LY3300054
Time Frame:Predose Cycle 1 Day 1 through Cycle 3 Day 1
Safety Issue:
Description:PK: Cmax of LY3381916 administered in combination with LY3300054
Measure:PK: AUC of LY3381916 Administered in Combination with LY3300054
Time Frame:Predose Cycle 1 Day 1 through Cycle 3 Day 1
Safety Issue:
Description:PK: AUC of LY3381916 administered in combination with LY3300054
Measure:PK: Cmax of LY3300054 Administered in Combination with LY3381916
Time Frame:Predose Cycle 1 Day 1 through Cycle 3 Day 1
Safety Issue:
Description:PK: Cmax of LY3300054 administered in combination with LY3381916
Measure:PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916
Time Frame:Predose Cycle 1 Day 1 through Cycle 3 Day 1
Safety Issue:
Description:PK: Cmin of LY3300054 administered in combination with LY3381916
Measure: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)
Safety Issue:
Description:ORR: Percentage of participants with a CR or PR
Measure:Time to Response (TTR)
Time Frame:Baseline to Date of CR or PR (Estimated up to 12 Months)
Safety Issue:
Description:TTR
Measure: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)
Safety Issue:
Description:DCR: Percentage of participants who exhibit SD, CR or PR
Measure: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)
Safety Issue:
Description:DOR
Measure:Progression Free Survival (PFS)
Time Frame:Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)
Safety Issue:
Description:PFS

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • IDO-1 Inhibitor
  • IDO1 Inhibitor
  • IDO Inhibitor

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