AzTrials
AzTrials

Solid TumorPhase 1NCT03099109

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

A Phase 1 study testing LY3321367 and LY3300054 in people with Solid Tumor, run by Eli Lilly and Company at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
LY3321367 and LY3300054
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
15 sitesin 4 countries
Study dates
12 Apr 2017to 30 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

United States8 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • Columbia University College of Phys & Surgeons

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Peggy and Charles Stephenson Oklahoma Cancer Center

    Oklahoma City, Oklahoma, 73104

  • The START Center for Cancer Care

    San Antonio, Texas, 78229

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

Other trials in United States

Spain3 sites

  • Fundación Jiménez Díaz-Oncology

    Madrid, 28040

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

Other trials in Spain

Japan2 sites

  • National Cancer Center Hospital

    Chuo-Ku, Tokyo, 104-0045

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277 8577

Other trials in Japan

South Korea2 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

Other trials in South Korea

About this study

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

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.

Conditions
Solid Tumor
Being tested
LY3321367, LY3300054
Keywords
TIM-3, PD-L1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3321367Drug

    Administered IV

  • LY3300054Drug

    Administered IV

Study groups in NCT03099109
Study groupRoleWhat they receive
LY3321367 Dose EscalationExperimentalLY3321367 given intravenously (IV).
Receives: Drug: LY3321367
LY3321367 + LY3300054 Dose EscalationExperimentalLY3321367 and LY3300054 given IV.
Receives: Drug: LY3321367; Drug: LY3300054
LY3321367 Dose ExpansionExperimentalLY3321367 given IV.
Receives: Drug: LY3321367
LY3321367 + LY3300054 Dose ExpansionExperimentalLY3321367 and LY3300054 given IV.
Receives: Drug: LY3321367; Drug: LY3300054
Japanese Arm D LY3321367ExperimentalLY3321367 given IV.
Receives: Drug: LY3321367
Japanese Arm E LY3300054ExperimentalLY3300054 given IV.
Receives: Drug: LY3300054
Japanese Arm F LY3321367 + LY3300054ExperimentalLY3321367 and LY3300054 given IV.
Receives: Drug: LY3321367; Drug: LY3300054

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline through Cycle 1 (28 Day Cycle)

Secondary outcomes (7)

  1. PK: Cmax of LY3321367

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

    Measured: Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)

  2. PK: Cmax of LY3321367 in Combination with LY3300054

    Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367 in Combination with LY3300054

    Measured: Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)

  3. 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).

    Measured: Baseline to Measured Progressive Disease (Estimated up to 6 Months)

  4. 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.

    Measured: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)

  5. 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.

    Measured: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)

  6. TTR

    Time to Response (TTR) is defined as time from treatment start to first documentation of response.

    Measured: Baseline to Date of CR or PR (Estimated up to 6 Months)

  7. 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).

    Measured: Baseline through Measured Progressive Disease (Estimated up to 6 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start12 Apr 2017
  3. Primary completion10 Dec 2019
  4. Study completion30 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03099109
Sponsor's protocol ID
16526
Other IDs
I9A-MC-JLDA, 2016-003195-42, 2016
Status last verified
Oct 2023
First submitted
28 Mar 2017
Last updated
17 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Harding JJ, Moreno V, Bang YJ, Hong MH, Patnaik A, Trigo J, Szpurka AM, Yamamoto N, Doi T, Fu S, Calderon B, Velez de Mendizabal N, Calvo E, Yu D, Gandhi L, Liu ZT, Galvao VR, Leow CC, de Miguel MJ. Blocking TIM-3 in Treatment-refractory Advanced Solid Tumors: A Phase Ia/b Study of LY3321367 with or without an Anti-PD-L1 Antibody. Clin Cancer Res. 2021 Apr 15;27(8):2168-2178. doi: 10.1158/1078-0432.CCR-20-4405. Epub 2021 Jan 29.

    PubMed 33514524

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3321367 and LY3300054 in people with Solid Tumor, run by Eli Lilly and Company at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Spain, Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with DLTs (time frame: Baseline through Cycle 1 (28 Day Cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03099109, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in