A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
Status: Recruiting
Location: See all (46) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Oregon
Oregon Health & Science University-Knight Cardiovascular Institute
RECRUITING
Portland
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Belgium
UZ Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
CHU Liege
RECRUITING
Liège
Canada
University Health Network (UHN) - Princess Margaret Cancer Centre
RECRUITING
Toronto
France
CHU Amiens Picardie Site Sud
RECRUITING
Amiens
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
RECRUITING
Bordeaux
Centre Hospitalier de Versailles (CHV)
WITHDRAWN
Le Chesnay
CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
RECRUITING
Lille
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
RECRUITING
Limoges
Centre Leon Berard
RECRUITING
Lyon
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Germany
Uniklinik RWTH Aachen Medizinische
RECRUITING
Aachen
Charite Campus Virchow
RECRUITING
Berlin
Klinikum der Goethe Universitat
RECRUITING
Frankfurt
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
RECRUITING
Homburg
Universitaetsklinikum Jena
RECRUITING
Jena
Medizinische Universitatsklinik Mannheim der Universitat Heidelberg
RECRUITING
Mannheim
Universitaetsmedizin Rostock
RECRUITING
Rostock
Hungary
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
RECRUITING
Budapest
Pecsi Tudomanyegyetem Klinikai Kozpont (University of Pecs, Clinical Centre)
RECRUITING
Pécs
Israel
Hadassah Medical Center
RECRUITING
Jerusalem
The Galilee Medical Center
RECRUITING
Nahariya
Rabin Medical Center
RECRUITING
Petah Tikva
Italy
Azienda Ospedaliero Universitaria Delle Marche
RECRUITING
Ancona
Netherlands
Radboud University Medical Center
RECRUITING
Nijmegen
Poland
Szpital Specjalistycnzy im. Jedrzeja Sniadeckiego w Nowym Saczu
RECRUITING
Nowy Sącz
MICS Centrum Medyczne Torun
RECRUITING
Torun
Instytut Hematologii I Transfuzjologii
RECRUITING
Warsaw
Republic of Korea
Keimyung University Dongsan Hospital
WITHDRAWN
Daegu
Uijeongbu Eulji Medical Center
RECRUITING
Gyeonggi-do
Chonnam National University Hwasun Hospital
WITHDRAWN
Hwasun
Chonbuk National University Hospital
WITHDRAWN
Jeonju
Samsung Medical Center
WITHDRAWN
Seoul
Spain
Hospital Del Mar
RECRUITING
Barcelona
Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario e Salud (SCS)
WITHDRAWN
Las Palmas De Gran Canaria
Hospital Universitario La Paz
RECRUITING
Madrid
Complejo Hospitalario de Toledo - Hospital Virgen de la Salud
TERMINATED
Toledo
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
RECRUITING
Valencia
United Kingdom
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital
RECRUITING
Glasgow
Hammersmith Hospital Imperial College Healthcare NHS Trust
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Study Contact
ELVN-001-101@enliventherapeutics.com
707-799-3272
Time Frame
Start Date: 2022-05-22
Estimated Completion Date: 2026-12
Participants
Target number of participants: 200
Treatments
Experimental: Phase 1a Dose Escalation
ELVN-001 administered in 3+3 dose escalation
Experimental: Phase 1b Dose Expansion (non-T315I)
ELVN-001 administered at one or more recommended dose(s) for expansion in CML without T315I mutations
Experimental: Phase 1b expansion (T315I)
ELVN-001 administered at the recommended dose for expansion for CML with T315I mutation
Related Therapeutic Areas
Sponsors
Leads: Enliven Therapeutics