Solid Tumor Clinical Trial
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
Verified date | June 2020 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 60 |
Est. completion date | May 4, 2020 |
Est. primary completion date | February 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Institut Jules Bordet | Brussel | |
Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
Belgium | Universitair Ziekenhuis Gent | Gent | |
Denmark | Finsen Institute | Copenhagen | |
France | Gustave Roussy | Villejuif Cedex | |
Italy | Azienda Ospedaliera Umberto I | Ancona | |
Italy | Azienda Ospedaliera San Gerardo | Monza | Milano |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | Hospital Clinico Universitario Virgen de la Victoria | Malaga | Andalucia |
United States | IU Simon Cancer Center | Indianapolis | Indiana |
United States | Sarah Cannon Research Institute SCRI | Nashville | Tennessee |
United States | Tennessee Oncology PLLC | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, Belgium, Denmark, France, Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Dose Limiting Toxicities (DLTs) | Number of participants with DLTs | Baseline through Cycle 1 (28 Day Cycle) | |
Secondary | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916 | PK: Cmax of LY3381916 | Predose Lead in Day 1 through Cycle 3 Day 1 | |
Secondary | PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916 | PK: AUC of LY3381916 | Predose Lead in Day 1 through Cycle 3 Day 1 | |
Secondary | PK: Cmax of LY3381916 Administered in Combination with LY3300054 | PK: Cmax of LY3381916 administered in combination with LY3300054 | Predose Cycle 1 Day 1 through Cycle 3 Day 1 | |
Secondary | PK: AUC 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 | |
Secondary | PK: Cmax of LY3300054 Administered in Combination with LY3381916 | PK: Cmax of LY3300054 administered in combination with LY3381916 | Predose Cycle 1 Day 1 through Cycle 3 Day 1 | |
Secondary | PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916 | PK: Cmin of LY3300054 administered in combination with LY3381916 | Predose Cycle 1 Day 1 through Cycle 3 Day 1 | |
Secondary | Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) | ORR: Percentage of participants with a CR or PR | Baseline through Measured Progressive Disease (Estimated up to 12 Months) | |
Secondary | Time to Response (TTR) | TTR | Baseline to Date of CR or PR (Estimated up to 12 Months) | |
Secondary | Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR | DCR: Percentage of participants who exhibit SD, CR or PR | Baseline through Measured Progressive Disease (Estimated up to 12 Months) | |
Secondary | Duration of Response (DOR) | DOR | Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) | |
Secondary | Progression Free Survival (PFS) | PFS | Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months) |
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