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

October 16, 2023 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
209

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline through Cycle 1 (28 Day Cycle)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)
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
Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)
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).
Baseline to Measured Progressive Disease (Estimated up to 6 Months)
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 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)
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.
Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
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.
Baseline to Date of CR or PR (Estimated up to 6 Months)
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).
Baseline through Measured Progressive Disease (Estimated up to 6 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16526
  • I9A-MC-JLDA (Other Identifier: Eli Lilly and Company)
  • 2016-003195-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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