Clinical Trial: A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 1a/1b Study of a Novel Anti-PD-L1 Checkpoint Antibody (LY3300054) Administered Alone or in Combination With Other Agents in Advanced Refractory Solid Tumors (Phase 1a/1b Anti-PD-L1 Combination
Brief Summary: The main purpose of this study is to evaluate the safety and tolerability of anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced refractory solid tumors.
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome: Number of Participants with LY3300054 Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (Approximately 28 Days) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3300054 [ Time Frame: Predose Cycle 1 Day 1 Through Follow Up (Approximately 6 Months) ]
- PK: Cmax of Ramucirumab [ Time Frame: Predose Cycle 1 Day 1 Through Follow Up (Approximately 6 Months) ]
- PK: Cmax of Abemaciclib [ Time Frame: Predose Cycle 1 Day 1 Through Follow Up (Approximately 6 Months) ]
- PK: Cmax of Merestinib [ Time Frame: Predose Cycle 1 Day 1 Through Follow Up (Approximately 6 Months) ]
- Objective Response Rate (ORR): Proportion of Participants With a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to Measured Progressive Disease (Approximately 6 Months ) ]
- Progression Free Survival (PFS) [ Time Frame: Baseline to Measured Progressive Disease or Death (Approximately 12 Months) ]
- Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Measured Progressive Disease or Death Due to Any Cause (Approximately 12 Months) ]
- Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Approximately 6 Months) ]
- Disease Control Rate (DCR): Proportion of Participants who Exhibit Stable Disease (SD), CR or PR [ Time Frame: Baseline to Measured Progressive Disease (Approximately 6 Months) ]
Original Secondary Outcome:
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3300054 [ Time Frame: Predose Cycle 1 Day 1 Through Follow Up (Approximately 6 Months) ]
- PK: Cmax of Ramucirumab and Necitumumab [ Time Frame: Predose Cycle 1 Day 1 Through Follow Up (Approximately 6 Months) ]
- Objective Response Rate (ORR): Proportion of Participants With a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to Measured Progressive Disease (Approximately 6 Months ) ]
- Progression Free Survival (PFS) [ Time Frame: Baseline to Measured Progressive Disease or Death (Approximately 12 Months) ]
- Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Measured Progressive Disease or Death Due to Any Cause (Approximately 12 Months) ]
- Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Approximately 6 Months) ]
- Disease Control Rate (DCR): Proportion of Participants who Exhibit Stable Disease (SD), CR or PR [ Time Frame: Baseline to Measured Progressive Disease (Approximately 6 Months) ]
Information By: Eli Lilly and Company
Dates:
Date Received: June 1, 2016
Date Started: June 29, 2016
Date Completion: July 6, 2018
Last Updated: April 7, 2017
Last Verified: April 2017