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).
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
Drug | Synonyms | Arms |
---|
LY3381916 | | LY3381916 + LY3300054 Escalation |
LY3300054 | | LY3381916 + 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
Name | Type | Description | Interventions |
---|
LY3381916 Escalation | Experimental | LY3381916 administered orally. | |
LY3381916 + LY3300054 Escalation | Experimental | LY3381916 administered orally and LY3300054 administered intravenously (IV). | |
LY3381916 Expansion | Experimental | LY3381916 administered orally. | |
LY3381916 + LY3300054 Expansion B1 | Experimental | Metastatic triple negative breast cancer (TNBC)
LY3381916 administered orally and LY3300054 administered IV. | |
LY3381916 + LY3300054 Expansion B2 | Experimental | Metastatic non-small cell lung cancer (NSCLC)
LY3381916 administered orally and LY3300054 administered IV. | |
LY3381916 + LY3300054 Expansion B3 | Experimental | Metastatic clear cell carcinoma renal cell carcinoma (RCC)
LY3381916 administered orally and LY3300054 administered IV. | |
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: | Terminated |
Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
- IDO-1 Inhibitor
- IDO1 Inhibitor
- IDO Inhibitor
Last Updated
June 9, 2020