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Taking people in IsraelPhase 1

Tests ELVN-001 in adults with chronic myeloid leukemia

Tests the new drug ELVN-001 for safety in adults with chronic myeloid leukemia.

Key facts

Who runs it
Enliven Therapeutics
Where
Jerusalem, Nahariya, and Petah Tikva, IsraelSee the 3 sitesAlso in 13 other countries, 39 sites
Registry title
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Status
Recruiting
Phase
Phase 1
People taking part
250 people, planned
Started
22 May 2022
Expected to end
Dec 2027
Type of study
Interventional, 3 groups
Treatments tested
  • ELVN-001
Record updated
1 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic-phase chronic myeloid leukemia (BCR-ABL1 positive) whose earlier treatments failed or caused problems. It tests the safety and dose of ELVN-001.

Age
18 years or older
Sex
All sexes can join
Disease stage
BCR-ABL1 positive chronic myeloid leukemia (CML) in chronic phase, with or without a T315I mutation
Earlier treatment
In the US: at least one earlier second-generation TKI or asciminib failed or was not tolerated. Elsewhere: available CML therapies failed, were not tolerated, or the person is not a candidate for them. An earlier bone marrow transplant is allowed if it was at least 6 months before the first dose.
Biomarker or test result
BCR-ABL1 positive; the T315I mutation may be present or absent

Main reasons for not taking part

  • Anti-cancer or anti-CML treatment within 7 days or 5 half-lives, whichever is longer
  • TKI-related pancreatitis within the last 6 months
  • Active chronic pancreatitis or any pancreas disease
  • QTc above 470 ms

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • BCR-ABL1 positive CML in chronic phase, with or without T315I mutation
  • US: The patient has failed or is intolerant to at least one prior second-generation tyrosine kinase inhibitor (TKI) or asciminib. Rest of World: The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML (country-specific criteria may vary)
  • ECOG performance status of 0 to 2
  • Adequate hematologic, hepatic and renal function
  • Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001

Who cannot take part

  • 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

Where in Israel

Also in 13 other countries, 39 sites

  • Hadassah medical CenterJerusalem, IsraelContact: David Lavie, Dr.Taking people
  • The Galilee Medical CenterNahariya, IsraelContact: Galia Stemer, Dr.Taking people
  • Rabin Medical CenterPetah Tikva, IsraelContact: Adi Shacham-Abulafia, Dr.Taking people

About the trial

What the trial wants to find out

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

The 3 groups in the trial

  • Phase 1a Dose EscalationTreatment being tested

    ELVN-001 administered in 3+3 dose escalation

    Treatment: ELVN-001

  • Phase 1b Dose Expansion (non-T315I)Treatment being tested

    ELVN-001 administered at one or more recommended dose(s) for expansion in CML without T315I mutations

    Treatment: ELVN-001

  • Phase 1b expansion (T315I)Treatment being tested

    ELVN-001 administered at the recommended dose for expansion for CML with T315I mutation

    Treatment: ELVN-001

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
Plain-language title
Tests ELVN-001 in adults with chronic myeloid leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 April 2026