Chronic Myeloid LeukemiaPhase 1CMLNCT05304377
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
A Phase 1 study testing ELVN-001 in people with Chronic Myeloid Leukemia and Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, run by Enliven Therapeutics at 45 sites in 14 countries.
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 patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Cml
- 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
- 250 participants
- Where
- 45 sitesin 14 countries
- Study dates
- 22 May 2022to Dec 2027
- 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 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 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
45 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
45 sites in 14 countries
Germany7 sites, 7 recruiting
- Recruiting
Uniklinik RWTH Aachen Medizinische
Aachen, 52074
Martina Crysandt, Dr, +49 241 8080862
- Recruiting
Charite Campus Virchow
Berlin, 13353
Philipp Le Coutre, Dr, +49 30 450 665 307
- Recruiting
Klinikum der Goethe Universitat
Frankfurt, 60596
Fabian Lang, Dr, +49 821 4861274
- Recruiting
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
Homburg, 66421
Sarah Altmeyer, Dr, +49 68411615001
- Recruiting
Universitaetsklinikum Jena
Jena, 07747
Andreas Hochhaus, Prof Dr, +49 3641 934200
- Recruiting
Medizinische Universitatsklinik Mannheim der Universitat Heidelberg
Mannheim, 68167
Susanne Saussele, Prof Dr, +49 621 383 6966
- Recruiting
Universitaetsmedizin Rostock
Rostock, 18057
Christian Junghanss, Dr, +49 3814947421
France6 sites, 5 recruiting
- Recruiting
CHU Amiens Picardie Site Sud
Amiens, 80054
Amandine Charbonnier, Dr, +33 322455914
- Recruiting
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
Gabriel Etienne, Dr, +33 5 56 33 33 33
- Recruiting
CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
Lille, 59000
Valerie Coiteux, Dr, +33 3 20 44 59 62
- Recruiting
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
Limoges, 87000
Pascal Turlure, Dr, +33 5 55 05 55 55
- Recruiting
Centre Leon Berard
Lyon, 69008
Franck Nicolini, Dr, +33 478782737
- Withdrawn
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
South Korea5 sites, 1 recruiting
- Withdrawn
Keimyung University Dongsan Hospital
Daegu, 42601
- Recruiting
Uijeongbu Eulji Medical Center
Gyeonggi-do, 11749
Dong-Wook Kim, Dr, +82 3118990001
- Withdrawn
Chonnam National University Hwasun Hospital
Hwasun, 58128
- Withdrawn
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
- Withdrawn
Samsung Medical Center
Seoul, 06351
Spain5 sites, 3 recruiting
- Recruiting
Hospital Del Mar
Barcelona, 08003
Patricia Velez Tenza, Dr, +34 932 48 30 00
- Withdrawn
Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario e Salud (SCS)
Las Palmas de Gran Canaria, 35010
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Maria Raquel de Paz Arias, Dr, +34 917 27 70 00
- Terminated
Complejo Hospitalario de Toledo - Hospital Virgen de la Salud
Toledo, 45007
- Recruiting
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
Elvira Mora Castera, Dr, +34 961 24 40 00
United States4 sites, 4 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Fadi Haddad, MD, 877-632-6789
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Michael Mauro, MD, +1 347 798 9213
- Recruiting
Oregon Health & Science University-Knight Cardiovascular Institute
Portland, Oregon, 97239
Michael Heinrich, MD, (503) 418-1964
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
David Levitz MD, 718-920-4321
Belgium3 sites, 3 recruiting
- Recruiting
UZ Gent
Ghent, 9000
Dominiek Mazure, Dr., +32 9 332 21 11
- Recruiting
UZ Leuven
Leuven, 3000
Peter Vandenberghe, Dr., +32 16 33 22 11
- Recruiting
CHU Liege
Liège, 4000
Marie Lejeune, Dr., +32 4 323 00 00
Israel3 sites, 3 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
David Lavie, Dr., +972 02-6779267
- Recruiting
The Galilee Medical Center
Nahariya, 2210001
Galia Stemer, Dr., +972 04-9107301
- Recruiting
Rabin Medical Center
Petah Tikva, 4941492
Adi Shacham-Abulafia, Dr., +972 03-9377909
Poland3 sites, 3 recruiting
- Recruiting
Szpital Specjalistycnzy im. Jedrzeja Sniadeckiego w Nowym Saczu
Nowy Sącz, 33-300
Szymon Fornagiel, Dr, +48 18 443 88 77
- Recruiting
MICS Centrum Medyczne Torun
Torun, 87-100
Dominik Chraniuk, Dr., +48 662 062 410
- Recruiting
Instytut Hematologii I Transfuzjologii
Warsaw, 02-776
Ewa Lech-Maranda, Dr., +48 22 349 61 00
United Kingdom3 sites, 3 recruiting
- Recruiting
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital
Glasgow, G12 0YN
Mhairi Copland, Dr, +44 141 301 7000
- Recruiting
Hammersmith Hospital Imperial College Healthcare NHS Trust
London, W12 0HS
Dragana Milojkovic, Dr., +44 20 3313 8335
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
John Chadwick, Dr, +44 (0) 161 446 3000
Hungary2 sites, 2 recruiting
- Recruiting
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, 1083
Istvan Tackas MD, +36 1 459 1500
- Recruiting
Pecsi Tudomanyegyetem Klinikai Kozpont (University of Pecs, Clinical Centre)
Pécs, 7624
Hussain Alizadeh, Dr, +36 72 501 500
Australia1 site, 1 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, SA 5000
Naranie Shanmuganathan, Dr, +61 8 7074 0000
Canada1 site, 1 recruiting
- Recruiting
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Dong Hwan Dennis Kim, Dr, +1 416 946 4501 ext. 2464
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Delle Marche
Ancona, 60126
Erika Morsia, Dr., +39 071 5961
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen, 6525
N.M.A. Blijlevens, Dr., +31 (0)24 361 11 11
About this study
Official title: A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
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.
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 do not tolerate or benefit from available TKIs.
- Being tested
- ELVN-001
- Keywords
- CML, Tyrosine kinase inhibitor, T315I, T315I mutant, BCR-ABL, ENABLE, active site inhibitor of 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 group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | ELVN-001 administered in 3+3 dose escalation Receives: Drug: ELVN-001 |
| Phase 1b Dose Expansion (non-T315I) | Experimental | ELVN-001 administered at one or more recommended dose(s) for expansion in CML without T315I mutations Receives: Drug: ELVN-001 |
| Phase 1b expansion (T315I) | Experimental | ELVN-001 administered at the recommended dose for expansion for CML with T315I mutation Receives: Drug: ELVN-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Incidence of dose limiting toxicities
DLTs will be used to support that the recommended doses for expansion are </= MTD
Measured: 28 days
Phase 1a: 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
Phase 1a: 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
Phase 1a: 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
Phase 1b: Incidence of adverse events
Adverse events will be used to support that the dose(s) evaluated in expansion is tolerable
Measured: up to 3 years
Phase 1b: Incidence of clinically significant laboratory abnormalities
Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in expansion is tolerable
Measured: up to 3 years
Phase 1b: Incidence of clinically significant ECG abnormalities
Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in expansion is tolerable
Measured: up to 3 years
Secondary outcomes (7)
Phase 1a and 1b: area under the curve
PK parameter based on measurement of drug concentration in blood over time
Measured: 6 months
Phase 1a and 1b: maximum concentration
PK parameter based on measurement of drug concentration in blood
Measured: 6 months
Phase 1a and 1b: 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
Phase 1a and 1b: 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
Phase 1a and 1b: Molecular response (MR)
measured by quantitative polymerase chain reaction of BCR-ABL transcript levels
Measured: up to 3 years
Phase 1b: 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
Phase 1b: 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.
- First posted31 Mar 2022
- Study start22 May 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enliven Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304377
- Sponsor's protocol ID
- ELVN-001-101
- Acronym
- CML
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05304377
- Acronym / sponsor ID
- CML / ELVN-001-101
- Keywords
- CML, Tyrosine kinase inhibitor, T315I, T315I mutant, BCR-ABL, ENABLE, active site inhibitor of BCR-ABL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Enliven TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 May 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 do not tolerate or benefit from available TKIs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Drug: ELVN-001ELVN-001 administered in 3+3 dose escalation |
| Phase 1b Dose Expansion (non-T315I) | Experimental | Drug: ELVN-001ELVN-001 administered at one or more recommended dose(s) for expansion in CML without T315I mutations |
| Phase 1b expansion (T315I) | Experimental | Drug: ELVN-001ELVN-001 administered at the recommended dose for expansion for CML with T315I mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELVN-001orally once or twice daily | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion (non-T315I), Phase 1b expansion (T315I) |
Primary outcome
Phase 1a: Incidence of dose limiting toxicities
Time frame: 28 days
DLTs will be used to support that the recommended doses for expansion are </= MTD
Phase 1a: Incidence of adverse events (AEs)
Time frame: up to 28 days
Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable
Phase 1a: Incidence of clinically significant laboratory abnormalities
Time frame: up to 28 days
Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Phase 1a: Incidence of clinically significant ECG abnormalities
Time frame: up to 28 days
Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Phase 1b: Incidence of adverse events
Time frame: up to 3 years
Adverse events will be used to support that the dose(s) evaluated in expansion is tolerable
Phase 1b: Incidence of clinically significant laboratory abnormalities
Time frame: up to 3 years
Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in expansion is tolerable
Phase 1b: Incidence of clinically significant ECG abnormalities
Time frame: up to 3 years
Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in expansion is tolerable
7 secondary outcomes
Phase 1a and 1b: area under the curve
Time frame: 6 months
Phase 1a and 1b: maximum concentration
Time frame: 6 months
Phase 1a and 1b: time of maximum concentration
Time frame: 6 months
Phase 1a and 1b: minimum concentration
Time frame: 6 months
Phase 1a and 1b: Molecular response (MR)
Time frame: up to 3 years
Phase 1b: Duration of Molecular Response
Time frame: up to 3 years
Phase 1b: Complete Hematologic Response (CHR)
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
45 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ELVN-001 in people with Chronic Myeloid Leukemia and Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, run by Enliven Therapeutics at 45 sites in 14 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 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Germany, France, South Korea, Spain, United States and 9 more countries. 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 Study Contact (707-799-3272, ELVN-001-101@enliventherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: 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?
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 Apr 2026.