The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
209
The University of Arizona Cancer Center
Tucson, Arizona, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Number of Participants with DLTs
Dose Limiting Toxicity (DLT) is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Time frame: Baseline through Cycle 1 (28 Day Cycle)
PK: Cmax of LY3321367
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367
Time frame: Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)
PK: Cmax of LY3321367 in Combination with LY3300054
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367 in Combination with LY3300054
Time frame: Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)
ORR: Percentage of Participants With a CR or PR
Objective Response Rate (ORR) is the percentage of participants with confirmed best overall tumor response of Complete Response (CR) or Partial Response (PR).
Time frame: Baseline to Measured Progressive Disease (Estimated up to 6 Months)
PFS
Progression Free Survival (PFS) is defined as the date of the first dose to the first date of objectively determined progressive disease or death from any cause, whichever is earlier.
Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)
DoR
Duration of Response (DoR) is defined as the time from the date of the first CR or PR to the first date of progressive disease (PD) or death from any cause.
Time frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
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Columbia University College of Phys & Surgeons
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
The START Center for Cancer Care
San Antonio, Texas, United States
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan
...and 5 more locations
TTR
Time to Response (TTR) is defined as time from treatment start to first documentation of response.
Time frame: Baseline to Date of CR or PR (Estimated up to 6 Months)
DCR: Percentage of Participants who Exhibit SD, CR or PR
Disease Control Rate (DCR) is the percentage of participants with stable disease (SD), confirmed PR or confirmed CR (CR+PR+SD).
Time frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months)