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

ID: NCT03099109
Status: Recruiting
Phase: Phase 1
Start Date: April 12, 2017
First Submitted: March 28, 2017
Last Updated: February 14, 2018
Results: N/A
Organization: Eli Lilly and Company
Sponsors & Collaborators: Eli Lilly and Company
Location: Korea, Republic of, Spain, United States
Conditions: Solid Tumor
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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.

Detailed Description

Condition or disease Intervention/treatment Phase

Solid Tumor

Drug: LY3321367
Other Names
Drug: LY3300054
Other Names
Phase 1

Tracking Information

First Submitted DateMarch 28, 2017
Last Update Posted DateFebruary 14, 2018
Actual Start DateApril 12, 2017
Anticipated Completion DateJune 14, 2020
Actual Primary Completion DateJune 14, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Number of Participants with DLTs [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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • PK: Cmax of LY3321367 [Time Frame: 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 [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

  • ORR: Percentage of Participants With a CR or PR [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).

  • PFS [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 time from randomization to the first date of objectively determined progressive disease or death from any cause, whichever is earlier.

  • DoR [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.

  • TTR [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.

  • DCR: Percentage of Participants who Exhibit SD, CR or PR [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).

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors
Official TitleA 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
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

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
172
Allocation
Non-Randomized
Interventional Model
Sequential Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Solid Tumor
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: LY3321367

Administered IV

Other Names
Drug: LY3300054

Administered IV

Other Names
Study Groups/Cohorts
LY3321367 Dose Escalation
LY3321367 given intravenously (IV).

LY3321367 + LY3300054 Dose Escalation
LY3321367 and LY3300054 given IV.

LY3321367 Dose Expansion
LY3321367 given IV.

LY3321367 + LY3300054 Dose Expansion
LY3321367 and LY3300054 given IV.

Study Arms
Experimental LY3321367 + LY3300054 Dose Escalation
LY3321367 and LY3300054 given IV.
Drug : LY3321367
Administered IV

Experimental LY3321367 + LY3300054 Dose Escalation
LY3321367 and LY3300054 given IV.
Drug : LY3300054
Administered IV

Experimental LY3321367 + LY3300054 Dose Expansion
LY3321367 and LY3300054 given IV.
Drug : LY3300054
Administered IV

Experimental LY3321367 + LY3300054 Dose Expansion
LY3321367 and LY3300054 given IV.
Drug : LY3321367
Administered IV

Experimental LY3321367 Dose Escalation
LY3321367 given intravenously (IV).
Drug : LY3321367
Administered IV

Experimental LY3321367 Dose Expansion
LY3321367 given IV.
Drug : LY3321367
Administered IV

Arm Intervention/Treatment
Experimental LY3321367 + LY3300054 Dose Escalation
LY3321367 and LY3300054 given IV.
Drug : LY3321367
Experimental LY3321367 + LY3300054 Dose Escalation
LY3321367 and LY3300054 given IV.
Drug : LY3300054
Experimental LY3321367 + LY3300054 Dose Expansion
LY3321367 and LY3300054 given IV.
Drug : LY3300054
Experimental LY3321367 + LY3300054 Dose Expansion
LY3321367 and LY3300054 given IV.
Drug : LY3321367
Experimental LY3321367 Dose Escalation
LY3321367 given intravenously (IV).
Drug : LY3321367
Experimental LY3321367 Dose Expansion
LY3321367 given IV.
Drug : LY3321367

Recruitment Information

Recruitment Status:Recruiting
Enrollment172
Completion DateJune 14, 2020
Eligibility Criteria: 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 not have experienced a Grade ≥3 immune-related AE or an immune-related neurologic or ocular AE, pneumonitis or cardiomyopathy of any grade while receiving prior immunotherapy.
- Must not have required immunosuppressive agents, other than corticosteroids for the management of an adverse event and not currently requite maintenance doses of >10 milligrams (mg) prednisone (or equivalent) per day.
- Must have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Korea, Republic of
Spain
United States

Administrative Information

NCT Number:NCT03099109
Other Study ID Numbers
16526
I9A-MC-JLDA
2016-003195-42
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Eli Lilly and Company
Collaborators
Not Available
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