A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors
- Conditions
- Solid Tumor
- Interventions
- Drug: LY3321367Drug: LY3300054
- Registration Number
- NCT03099109
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
-
For Ph1a monotherapy and combination cohorts, histologic or cytologic confirmation of advanced solid tumor.
-
For Phase 1a and 1b, prior PD-1 or PD-L1 therapy or other immunotherapy is allowed, if the following criteria are met:
- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- Must have completely recovered or recovered to baseline prior to screening from any prior AEs occurring while receiving prior immunotherapy.
-
Must have provided tumor tissue sample, as follows:
- For participants entering Ph1a: have submitted, if available, an archival tumor tissue sample.
- For participants entering Ph1b: have submitted, a sample from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by 6 months of study enrollment (Ph1b).
-
Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
-
Must have adequate organ function.
-
Have an estimated life expectancy of 12 weeks, in judgement of the investigator.
- Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are eligible).
- Have received a live vaccine within 30 days before the first dose of study treatment.
- If female, is pregnant, breastfeeding, or planning to become pregnant.
- Have a history or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the participant's participation.
- Have moderate or severe cardiovascular disease.
- Have a serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including active or chronic infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment.
- Use of escalating or chronic supraphysiologic doses of corticosteroids or immunosuppressive agents (such as, cyclosporine). [Use of topical, ophthalmic, inhaled, and intranasal corticosteroids permitted].
- Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
- Evidence of interstitial lung disease or noninfectious pneumonitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description LY3321367 + LY3300054 Dose Expansion LY3321367 LY3321367 and LY3300054 given IV. Japanese Arm F LY3321367 + LY3300054 LY3300054 LY3321367 and LY3300054 given IV. LY3321367 Dose Escalation LY3321367 LY3321367 given intravenously (IV). LY3321367 Dose Expansion LY3321367 LY3321367 given IV. LY3321367 + LY3300054 Dose Expansion LY3300054 LY3321367 and LY3300054 given IV. Japanese Arm E LY3300054 LY3300054 LY3300054 given IV. LY3321367 + LY3300054 Dose Escalation LY3321367 LY3321367 and LY3300054 given IV. LY3321367 + LY3300054 Dose Escalation LY3300054 LY3321367 and LY3300054 given IV. Japanese Arm F LY3321367 + LY3300054 LY3321367 LY3321367 and LY3300054 given IV. Japanese Arm D LY3321367 LY3321367 LY3321367 given IV.
- Primary Outcome Measures
Name Time Method Number of Participants with DLTs 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.
- Secondary Outcome Measures
Name Time Method TTR 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.
PK: Cmax of LY3321367 Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months) Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367
PK: Cmax of LY3321367 in Combination with LY3300054 Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months) Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367 in Combination with LY3300054
ORR: Percentage of Participants With a CR or PR 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).
PFS 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.
DCR: Percentage of Participants who Exhibit SD, CR or PR 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).
DoR 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.
Trial Locations
- Locations (15)
Fundación Jiménez Díaz-Oncology
🇪🇸Madrid, Spain
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hospital Madrid Norte Sanchinarro
🇪🇸Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucia, Spain
Columbia University College of Phys & Surgeons
🇺🇸New York, New York, United States
Peggy and Charles Stephenson Oklahoma Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
The START Center for Cancer Care
🇺🇸San Antonio, Texas, United States
The University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
National Cancer Center Hospital
🇯🇵Chuo-Ku, Tokyo, Japan
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Sarah Cannon Research Institute SCRI
🇺🇸Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States