A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099109
• Other study ID #: 16526
• Secondary ID: I9A-MC-JLDA2016-
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2017
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: August 30, 2023
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• LY3321367
Administered IV
• LY3300054
Administered IV

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo-Ku	Tokyo
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Spain	Fundación Jiménez Díaz-Oncology	Madrid
Spain	Hospital Madrid Norte Sanchinarro	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria	Malaga	Andalucia
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute SCRI	Nashville	Tennessee
United States	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	The START Center for Cancer Care	San Antonio	Texas
United States	The University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Japan,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through Cycle 1 (28 Day Cycle)
Secondary	PK: Cmax of LY3321367	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367	Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)
Secondary	PK: Cmax of LY3321367 in Combination with LY3300054	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367 in Combination with LY3300054	Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)
Secondary	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).	Baseline to Measured Progressive Disease (Estimated up to 6 Months)
Secondary	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.	Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)
Secondary	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.	Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Secondary	TTR	Time to Response (TTR) is defined as time from treatment start to first documentation of response.	Baseline to Date of CR or PR (Estimated up to 6 Months)
Secondary	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).	Baseline through Measured Progressive Disease (Estimated up to 6 Months)

External Links

•   A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors