A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

Last updated: May 28, 2025
Sponsor: Enliven Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Leukemia

Chronic Myeloid Leukemia

Platelet Disorders

Treatment

ELVN-001

Clinical Study ID

NCT05304377
ELVN-001-101
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.

  • The patient has failed, is intolerant to, or not a candidate for, availabletherapies known to be active for treatment of their CML.

  • 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 ofELVN-001.

Exclusion

Exclusion Criteria:

  • 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 6months of study entry. Active chronic pancreatitis, or pancreatic disease due to anycause.

  • QTc >470 ms.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: ELVN-001
Phase: 1
Study Start date:
May 22, 2022
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, SA 5000
    Australia

    Active - Recruiting

  • University Health Network (UHN) - Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • CHU Amiens Picardie Site Sud

    Amiens, 80054
    France

    Active - Recruiting

  • Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, 33076
    France

    Active - Recruiting

  • Centre Hospitalier de Versailles (CHV)

    Le Chesnay, 78157
    France

    Site Not Available

  • CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille

    Lille, 59000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

    Limoges, 87000
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69008
    France

    Active - Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre Benite Cedex, 69495
    France

    Active - Recruiting

  • Uniklinik RWTH Aachen Medizinische

    Aachen, 52074
    Germany

    Active - Recruiting

  • Uniklinik RWTH Aachen Medizinische Klinik III

    Aachen, 52074
    Germany

    Active - Recruiting

  • Charite Campus Virchow

    Berlin, 13353
    Germany

    Active - Recruiting

  • Klinikum der Goethe Universitat

    Frankfurt, 60596
    Germany

    Active - Recruiting

  • Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

    Homburg, 66421
    Germany

    Active - Recruiting

  • Universitaetsklinikum Jena

    Jena, 07747
    Germany

    Active - Recruiting

  • Medizinische Universitatsklinik Mannheim der Universitat Heidelberg

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Universitaetsmedizin Rostock

    Rostock, 18057
    Germany

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • The Galilee Medical Center

    Nahariya, 2210001
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do 54907
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Hospital

    Daegu, 42601
    Korea, Republic of

    Site Not Available

  • Uijeongbu Eulji Medical Center

    Gyeonggi-do, 11749
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Szpital Specjalistycnzy im. Jedrzeja Sniadeckiego w Nowym Saczu

    Nowy Sącz, 33-300
    Poland

    Active - Recruiting

  • Hospital Del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario de Salud (SCS)

    Las Palmas De Gran Canaria, 35010
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario e Salud (SCS)

    Las Palmas De Gran Canaria, 35010
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Complejo Hospitalario de Toledo - Hospital Virgen de la Salud

    Toledo, 45007
    Spain

    Terminated

  • Hospital Virgen de la Salud

    Toledo, 45007
    Spain

    Active - Recruiting

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    Valencia, 46026
    Spain

    Active - Recruiting

  • Beatson West of Scotland Cancer Centre, Gartnavel General Hospital

    Glasgow, G12 0YN
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital Imperial College Healthcare NHS Trust

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Oregon Health & Science University-Knight Cardiovascular Institute

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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