ELVN-001 for the Treatment Chronic Myeloid Leukemia [Australia, France, Germany, Republic of Korea, Spain, United States]
Type of study
Trial after therapy failure or intolerance
Phase
Current status
Recruiting
Study title
ELVN-001 for the Treatment Chronic Myeloid Leukemia (CML)
Scientific title
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (CML)
Other trial ID
ELVN-001-101, ClinicalTrials.gov NCT05304377, EudraCT no. 2022-000052-11
What is the purpose of the study
This is a study to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with or without T315I mutations who are relapsed, refractory or intolerant to tyrosine kinase inhibibitors (TKIs).
What will happen during the study
This is a first-in-human trial with ELVN-001, a new drug under investigation for the treatment of CML. ELVN-001 will be given orally once daily. The dose will be escalated to determine the recommended dose for further evaluation in patients with chronic phase or accelerated phase CML with and without T315I mutations. There will be four treatment groups.
The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed. Changes in BCR-ABL1 transcript will be evaluated.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 18 years or older
- have been diagnosed with CML in chronic phase (CP) or CML in accelerated phase (AP), with or without T315I mutation,
who are resistant and/or intolerant to a previous therapy for treatment of their CML - have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
- have adequate hematologic, liver and kidney function
Key exclusion criteria
This study does not include patients who:
- have been treated with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer
- have an active infection or whose heart, liver or pancreas function is impaired
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)
Study sponsor
Enliven Therapeutics
Scientific lead / contact
Principal investigator
Study centers / principal investigators
Australia
Adelaide, SA 5000 – Recruiting
Royal Adelaide Hospital
Principal Investigator: Timothy Hughes
France
Bordeaux, 33076 – Not yet recruiting
Institut Bergonie – Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Principal Investigator: Dr. Gabriel Etienne
Le Chesnay, 78157 – Not yet recruiting
Centre Hospitalier de Versailles (CHV)
Principal Investigator: Prof. Philippe Rousselot
Lille, 59000 – Not yet recruiting
CHRU de Lille – Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
Principal Investigator: Dr. Valerie Coiteux
Pierre Benite Cedex, 69495 – Recruiting
Centre Hospitalier Lyon Sud
Principal Investigator: Dr. Marie Balsat
Germany
Aachen, 52074 – Not yet recruiting
Uniklinik RWTH Aachen Medizinische Klinik III
Principal Investigator: Dr. Martina Crysandt
Berlin, 13353 – Not yet recruiting
Charite Campus Virchow
Principal Investigator: Dr. Philipp Le Coutre
Frankfurt, 60596 – Not yet recruiting
Klinikum der Goethe Universität
Principal Investigator: Dr. Fabian Lang
Jena, 07747 – Recruiting
Universitätsklinikum Jena
Principal Investigator: Prof. Dr. Andreas Hochhaus
Mannheim, 68167 – Not yet recruiting
Medizinische Universitätsklinik Mannheim der Universitat Heidelberg
Principal Investigator: Prof. Dr. Susanne Saussele
Korea, Republic of
Jeonju, Jeollabuk-do, 54907 – Recruiting
Chonbuk National University Hospital
Principal Investigator: Prof. Jae-Yong Kwak
Daegu, 42601 – Not yet recruiting
Keimyung University Dongsan Hospital
Principal Investigator: Prof. Dr. Young Rok Do
Gyeonggi-do, 11749 – Not yet recruiting
Uijeongbu Eulji Medical Center
Principal Investigator: Dr. Dong-Wook Kim
Hwasun, 58128 – Not yet recruiting
Chonnam National University Hwasun Hospital
Principal Investigator: Dr. Hyeoung-Joon Kim
Seoul, 06351 – Not yet recruiting
Samsung Medical Center
Principal Investigator: Dr. Chul Won Jung
Spain
Barcelona, 08003 – Recruiting
Hospital Del Mar
Principal Investigator: Dr. Patricia Velez Tenza
Las Palmas De Gran Canaria, 35010 – Not yet recruiting
Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario de Salud (SCS)
Principal Investigator: Dr. Maria Teresa Gomez-Casares
Madrid, 28046 – Not yet recruiting
Hospital Universitario La Paz
Principal Investigator: Dr. Maria Raquel de Paz Arias
Toledo, 45007 – Not yet recruiting
Hospital Virgen de la Salud
Principal Investigator: Dr. Luis Felipe Casado Montero
Valencia, 46026 – Not yet recruiting
Universitat de Valencia – Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Principal Investigator: Dr. Elvira Mora Castera
United States
New York
New York, New York, 10065 – Not yet recruiting
Memorial Sloan Kettering Cancer Center
Principal Investigator: Dr. Michael Mauro
Oregon
Portland, Oregon, 97239 – Not yet recruiting
Oregon Health & Science University-Knight Cardiovascular Institute
Principal Investigator: Dr. Michael Heinrich
Texas
Houston, Texas, 77030 – Not yet recruiting
The University of Texas MD Anderson Cancer Center
Principal Investigator: Dr. Koji Sasaki