A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
NCT ID: NCT05304377
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2022-05-22
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a Dose Escalation
ELVN-001 administered in 3+3 dose escalation
ELVN-001
orally once or twice daily
Phase 1b Dose Expansion (non-T315I)
ELVN-001 administered at one or more recommended dose(s) for expansion in CML without T315I mutations
ELVN-001
orally once or twice daily
Phase 1b expansion (T315I)
ELVN-001 administered at the recommended dose for expansion for CML with T315I mutation
ELVN-001
orally once or twice daily
Interventions
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ELVN-001
orally once or twice daily
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Enliven Therapeutics
INDUSTRY
Responsible Party
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Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Oregon Health & Science University-Knight Cardiovascular Institute
Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Royal Adelaide Hospital
Adelaide, , Australia
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHU Liege
Liège, , Belgium
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CHU Amiens Picardie Site Sud
Amiens, , France
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, , France
Centre Hospitalier de Versailles (CHV)
Le Chesnay, , France
CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
Lille, , France
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
Limoges, , France
Centre Leon Berard
Lyon, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Uniklinik RWTH Aachen Medizinische
Aachen, , Germany
Charite Campus Virchow
Berlin, , Germany
Klinikum der Goethe Universitat
Frankfurt, , Germany
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
Homburg, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Medizinische Universitatsklinik Mannheim der Universitat Heidelberg
Mannheim, , Germany
Universitaetsmedizin Rostock
Rostock, , Germany
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont (University of Pecs, Clinical Centre)
Pécs, , Hungary
Hadassah Medical Center
Jerusalem, , Israel
The Galilee Medical Center
Nahariya, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Azienda Ospedaliero Universitaria Delle Marche
Ancona, , Italy
Radboud University Medical Center
Nijmegen, , Netherlands
Szpital Specjalistycnzy im. Jedrzeja Sniadeckiego w Nowym Saczu
Nowy Sącz, , Poland
MICS Centrum Medyczne Torun
Torun, , Poland
Instytut Hematologii I Transfuzjologii
Warsaw, , Poland
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Uijeongbu Eulji Medical Center
Gyeonggi-do, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Del Mar
Barcelona, , Spain
Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario e Salud (SCS)
Las Palmas de Gran Canaria, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Complejo Hospitalario de Toledo - Hospital Virgen de la Salud
Toledo, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, , Spain
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital
Glasgow, , United Kingdom
Hammersmith Hospital Imperial College Healthcare NHS Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Michael Mauro, MD
Role: primary
David Levitz MD
Role: primary
Michael Heinrich, MD
Role: primary
Fadi Haddad, MD
Role: primary
Naranie Shanmuganathan, Dr
Role: primary
Dominiek Mazure, Dr.
Role: primary
Peter Vandenberghe, Dr.
Role: primary
Marie Lejeune, Dr.
Role: primary
Dong Hwan Dennis Kim, Dr
Role: primary
Amandine Charbonnier, Dr
Role: primary
Gabriel Etienne, Dr
Role: primary
Valerie Coiteux, Dr
Role: primary
Pascal Turlure, Dr
Role: primary
Franck Nicolini, Dr
Role: primary
Martina Crysandt, Dr
Role: primary
Philipp Le Coutre, Dr
Role: primary
Fabian Lang, Dr
Role: primary
Sarah Altmeyer, Dr
Role: primary
Andreas Hochhaus, Prof Dr
Role: primary
Susanne Saussele, Prof Dr
Role: primary
Christian Junghanss, Dr
Role: primary
Istvan Tackas MD
Role: primary
Hussain Alizadeh, Dr
Role: primary
David Lavie, Dr.
Role: primary
Galia Stemer, Dr.
Role: primary
Adi Shacham-Abulafia, Dr.
Role: primary
Erika Morsia, Dr.
Role: primary
N.M.A. Blijlevens, Dr.
Role: primary
Szymon Fornagiel, Dr
Role: primary
Dominik Chraniuk, Dr.
Role: primary
Ewa Lech-Maranda, Dr.
Role: primary
Dong-Wook Kim, Dr
Role: primary
Patricia Velez Tenza, Dr
Role: primary
Maria Raquel de Paz Arias, Dr
Role: primary
Elvira Mora Castera, Dr
Role: primary
Mhairi Copland, Dr
Role: primary
Dragana Milojkovic, Dr.
Role: primary
John Chadwick, Dr
Role: primary
Other Identifiers
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ELVN-001-101
Identifier Type: -
Identifier Source: org_study_id
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