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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03099109
• Collaborator: (none)
• Enrollment: 275
• Locations: 15
• Arms: 7
• Anticipated Duration (Months): 68.6
• Patients Per Site: 18.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: LY3321367; Drug: LY3300054	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 275 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 12, 2017
• Actual Primary Completion Date: Dec 10, 2019
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3321367 Dose Escalation LY3321367 given intravenously (IV).	Drug: LY3321367; Administered IV
Experimental: LY3321367 + LY3300054 Dose Escalation LY3321367 and LY3300054 given IV.	Drug: LY3321367; Administered IV; Drug: LY3300054; Administered IV
Experimental: LY3321367 Dose Expansion LY3321367 given IV.	Drug: LY3321367; Administered IV
Experimental: LY3321367 + LY3300054 Dose Expansion LY3321367 and LY3300054 given IV.	Drug: LY3321367; Administered IV; Drug: LY3300054; Administered IV
Experimental: Japanese Arm D LY3321367 LY3321367 given IV.	Drug: LY3321367; Administered IV
Experimental: Japanese Arm E LY3300054 LY3300054 given IV.	Drug: LY3300054; Administered IV
Experimental: Japanese Arm F LY3321367 + LY3300054 LY3321367 and LY3300054 given IV.	Drug: LY3321367; Administered IV; Drug: LY3300054; Administered IV

Outcome Measures

Primary Outcome Measures

1. 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

1. PK: Cmax of LY3321367 [Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)]

   Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367

2. 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

3. 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).

4. 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.

5. 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.

6. 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.

7. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Arizona Cancer Center	Tucson	Arizona	United States	85719
2	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
3	Columbia University College of Phys & Surgeons	New York	New York	United States	10032
4	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
5	Peggy and Charles Stephenson Oklahoma Cancer Center	Oklahoma City	Oklahoma	United States	73104
6	Sarah Cannon Research Institute SCRI	Nashville	Tennessee	United States	37203
7	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
8	The START Center for Cancer Care	San Antonio	Texas	United States	78229
9	National Cancer Center Hospital East	Kashiwa	Chiba	Japan	277 8577
10	National Cancer Center Hospital	Chuo-Ku	Tokyo	Japan	104-0045
11	Seoul National University Hospital	Seoul		Korea, Republic of	03080
12	Severance Hospital Yonsei University Health System	Seoul		Korea, Republic of	03722
13	Hospital Clinico Universitario Virgen de la Victoria	Malaga	Andalucia	Spain	29010
14	Fundación Jiménez Díaz-Oncology	Madrid		Spain	28040
15	Hospital Madrid Norte Sanchinarro	Madrid		Spain	28050

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM- 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03099109
• Other Study ID Numbers: 16526; I9A-MC-JLDA; 2016-003195-42
• First Posted: Apr 4, 2017
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eli Lilly and Company: TIM-3; PD-L1
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Sep 5, 2021