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CML (Chronic Myelogenous Leukemia)Phase 1CMLNCT06787144

ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants

A Phase 1 study testing ELVN-001 in people with CML (Chronic Myelogenous Leukemia) and Chronic Phase CML, run by Enliven Therapeutics at 4 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ELVN-001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
4 sitesJapan
Study dates
23 Jan 2025to Jan 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
  • ECOG performance status of 0 to 2.
  • The patient was born in Japan and both parents and grandparents are Japanese.
  • Adequate hematologic, hepatic and renal function.
  • Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.

Who cannot join

  • Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
  • History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.
  • QTc >470 ms.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yuzo Tomonaga contact

+81-3-6779-8000

ClinicalTrialInformation@cmic.co.jp

Japan4 sites, 4 recruiting

  • Akita University Hospital

    Akita, Akita

    Yuzo Tomonaga, +81-3-6779-8000

    Recruiting

  • Aiiku Hospital

    Sapporo, Hokkaido

    Yuzo Tomonaga, +81-3-6779-8000

    Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo

    Yuzo Tomonaga, +81-3-6779-8000

    Recruiting

  • The University of Osaka Hospital

    Suita-shi, Osaka

    Yuzo Tomonaga, +81-3-6779-8000

    Recruiting

Other trials in Japan

About this study

Official title: A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.

Read the detailed description

This first-in-human trial with ELVN-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (RDEs) of single agent ELVN-001 in chronic phase CML with or without T315I mutations. The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed together with an evaluation of changes in BCR-ABL1 transcript. An understanding of the safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development of ELVN-001 in adults with CML. By virtue of its predicted pharmacological profile ELVN-001 has the potential to be tolerable and achieve a deep molecular response in patients with CML with or without T315I mutations who have failed, or are intolerant to, or not a candidate for, at least 2 prior TKIs.

Being tested
ELVN-001
Keywords
CML, Tyrosine Kinase Inhibitor, T315I, T315I Mutant, BCR-ABL
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase

What participants receive

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

  • ELVN-001Drug

    Orally once or twice daily

Study groups in NCT06787144
Study groupRoleWhat they receive
Part 1 Dose EscalationExperimentalELVN-001 administered in 3+3 dose escalation
Receives: Drug: ELVN-001
Part 2 Dose ExplorationExperimentalELVN-001 administered to approximately 6 participants per dose level who may be enrolled at or below the dose levels that have been deemed safe and tolerable in Part 1
Receives: Drug: ELVN-001

What is being measured

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

  1. Part 1: Incidence of dose limiting toxicities

    DLTs will be used to support that the recommended doses for expansion are </= MTD

    Measured: 28 days

  2. Part 1: Incidence of adverse events (AEs)

    Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable

    Measured: Up to 28 days

  3. Part 1: Incidence of clinically significant laboratory abnormalities

    Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

    Measured: Up to 28 days

  4. Part 1: Incidence of clinically significant ECG abnormalities

    Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

    Measured: Up to 28 days

  5. Part 2: Incidence of adverse events

    Adverse events will be used to support that the dose(s) evaluated in exploration is tolerable

    Measured: Up to 3 years

  6. Part 2: Incidence of clinically significant laboratory abnormalities

    Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in exploration is tolerable

    Measured: Up to 3 years

  7. Part 2: Incidence of clinically significant ECG abnormalities

    Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in exploration is tolerable

    Measured: Up to 3 years

Secondary outcomes (7)

  1. Area under the curve

    PK parameter based on measurement of drug concentration in blood over time

    Measured: 6 months

  2. Maximum concentration

    PK parameter based on measurement of drug concentration in blood

    Measured: 6 months

  3. Time of maximum concentration

    PK parameter which is the time at which the highest concentration of drug in the blood is measured

    Measured: 6 months

  4. Minimum concentration

    PK parameter based on the measurement of the drug concentration that is at the lowest level once steady state has been achieved.

    Measured: 6 months

  5. Molecular response (MR)

    Measured by quantitative polymerase chain reaction of BCR-ABL transcript levels

    Measured: Up to 3 years

  6. Duration of Molecular Response

    Time from first molecular response (as measured by quantitative polymerase chain reaction of BCR-ABL transcript levels) to loss of response or discontinuation of study drug

    Measured: Up to 3 years

  7. Complete Hematologic Response (CHR)

    The proportion of patients who achieve a CHR who are not in CHR at baseline

    Measured: Up to 3 years

Timeline

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

  1. First posted22 Jan 2025
  2. Study start23 Jan 2025
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

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
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06787144
Sponsor's protocol ID
ELVN-001-105
Acronym
CML
Status last verified
Jun 2025
First submitted
16 Dec 2024
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ELVN-001 in people with CML (Chronic Myelogenous Leukemia) and Chronic Phase CML, run by Enliven Therapeutics at 4 sites in Japan.

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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yuzo Tomonaga (+81-3-6779-8000, ClinicalTrialInformation@cmic.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Incidence of dose limiting toxicities (time frame: 28 days). The study lists 7 primary outcomes in all. 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 NCT06787144.

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 1 Jul 2025.

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