ELVN-001 for the Treatment of Chronic Myeloid Leukemia [Australia, France, Germany, Republic of Korea, Spain, USA]

Type of study

Trial after therapy failure or intolerance, treatment of advanced phases

Phase

1a/1b

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

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.

Further criteria may apply. Please discuss these with your doctor or study staff.

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

December 2026

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study sponsor

Enliven Therapeutics

Scientific lead / contact

Principal investigator

Study centers / principal investigators

Australia

Royal Adelaide Hospital
Adelaide, SA 5000
Principal Investigator: Timothy Hughes

France

Institut Bergonie, Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
Principal Investigator: Dr. Gabriel Etienne

Centre Hospitalier de Versailles (CHV)
Le Chesnay, 78157
Principal Investigator: Prof. Philippe Rousselot

CHRU de Lille, Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
Lille, 59000
Principal Investigator: Dr. Valerie Coiteux

Centre Hospitalier Lyon Sud
Pierre Benite Cedex, 69495
Principal Investigator: Dr. Marie Balsat

Germany

Uniklinik RWTH Aachen Medizinische Klinik III
Aachen, 52074
Principal Investigator: Dr. Martina Crysandt

Charite Campus Virchow
Berlin, 13353
Principal Investigator: Dr. Philipp Le Coutre

Klinikum der Goethe Universität
Frankfurt, 60596
Principal Investigator: Dr. Fabian Lang

Universitätsklinikum Jena
Jena, 07747
Principal Investigator: Prof. Dr. Andreas Hochhaus

Medizinische Universitätsklinik Mannheim der Universität Heidelberg
Mannheim, 68167
Principal Investigator: Prof. Dr. Susanne Saussele

Korea, Republic of

Keimyung University Dongsan Hospital
Daegu, 42601
Principal Investigator: Prof. Dr. Young Rok Do

Uijeongbu Eulji Medical Center
Gyeonggi-do, 11749
Principal Investigator: Dr. Dong-Wook Kim

Chonnam National University Hwasun Hospital
Hwasun, 58128
Principal Investigator: Dr. Hyeoung-Joon Kim

Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Principal Investigator: Prof. Jae-Yong Kwak

Samsung Medical Center
Seoul, 06351
Principal Investigator: Dr. Chul Won Jung

Spain

Hospital Del Mar
Barcelona, 08003
Principal Investigator: Dr. Patricia Velez Tenza

Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario de Salud (SCS) – Not yet recruiting
Las Palmas De Gran Canaria, 35010
Principal Investigator: Dr. Maria Teresa Gomez-Casares

Hospital Universitario La Paz
Madrid, 28046
Principal Investigator: Dr. Maria Raquel de Paz Arias

Hospital Virgen de la Salud
Toledo, 45007
Principal Investigator: Dr. Luis Felipe Casado Montero

Universitat de Valencia, Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
Principal Investigator: Dr. Elvira Mora Castera

United States

New York

Memorial Sloan Kettering Cancer Center – Not yet recruiting
New York, New York, 10065
Principal Investigator: Dr. Michael Mauro

Oregon

Oregon Health & Science University-Knight Cardiovascular Institute
Portland, Oregon, 97239
Principal Investigator: Dr. Michael Heinrich

Texas

The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator: Dr. Koji Sasaki