LY3321367
DrugAdministered IV
NCT Number: NCT03099109
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered IV
Administered IV
Time frame: Baseline through Cycle 1 (28 Day Cycle)
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: Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367
Time frame: Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367 in Combination with LY3300054
Time frame: Baseline to Measured Progressive Disease (Estimated up to 6 Months)
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 Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)
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: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
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: Baseline to Date of CR or PR (Estimated up to 6 Months)
Time to Response (TTR) is defined as time from treatment start to first documentation of response.
Time frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months)
Disease Control Rate (DCR) is the percentage of participants with stable disease (SD), confirmed PR or confirmed CR (CR+PR+SD).
Eli Lilly and Company
Industry
A Phase 1a/1b Study of LY3321367, an Anti-TIM-3 Antibody, Administered Alone or in Combination With LY3300054, an Anti-PD-L1 Antibody, in Advanced Relapsed/Refractory Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05507736
Diarrhea, Neoplasms
Esplugues de Llobregat, Barcelona, Spain
View Trial DetailsNCT06209385
Solid Tumor
Nanchang, Jiangxi, China
View Trial DetailsNCT05991349
Solid Tumor
Camperdown, New South Wales, Australia
View Trial DetailsNCT05708950
Adnexal Diseases, Breast Cancer
Santa Monica, California, United States
View Trial Details