Solid Tumor, Non Small Cell Lung Cancer, Renal Cell Carcinoma, Triple Negative Breast Cancer
Conditions
Keywords
IDO-1 Inhibitor, IDO1 Inhibitor, IDO Inhibitor
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).
Interventions
DRUGLY3381916
IDO-1 inhibitor administered orally
DRUGLY3300054
PD-L1 inhibitor administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose Limiting Toxicities (DLTs) | Baseline through Cycle 1 (28 Day Cycle) | Number of participants with DLTs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916 | Predose Lead in Day 1 through Cycle 3 Day 1 | PK: AUC of LY3381916 |
| PK: Cmax of LY3381916 Administered in Combination with LY3300054 | 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 | 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 | 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 | Predose Cycle 1 Day 1 through Cycle 3 Day 1 | PK: Cmin of LY3300054 administered in combination with LY3381916 |
| Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916 | Predose Lead in Day 1 through Cycle 3 Day 1 | PK: Cmax of LY3381916 |
| Time to Response (TTR) | 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 | Baseline through Measured Progressive Disease (Estimated up to 12 Months) | DCR: Percentage of participants who exhibit SD, CR or PR |
| Duration of Response (DOR) | 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) | Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months) | PFS |
| Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) | Baseline through Measured Progressive Disease (Estimated up to 12 Months) | ORR: Percentage of participants with a CR or PR |
Countries
Belgium, Denmark, France, Italy, Spain, United States
Outcome results
None listed