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

NCT05304377 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ELVN-001-101
• Study Type: interventional
• Target: 250
• Locations: 14 countries
• Sites: 45

Brief 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.

Conditions

Chronic Myeloid Leukemia; Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive; Cml

Keywords

CML; Tyrosine kinase inhibitor; T315I; T315I mutant; BCR-ABL; ENABLE; active site inhibitor of BCR-ABL

Outcome Measures

Primary Outcomes (7)

• Phase 1a: Incidence of dose limiting toxicities

  DLTs will be used to support that the recommended doses for expansion are \</= MTD

  28 days

• Phase 1a: Incidence of adverse events (AEs)

  Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable

  up to 28 days

• Phase 1a: Incidence of clinically significant laboratory abnormalities

  Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

  up to 28 days

• Phase 1a: Incidence of clinically significant ECG abnormalities

  Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

  up to 28 days

• Phase 1b: Incidence of adverse events

  Adverse events will be used to support that the dose(s) evaluated in expansion is tolerable

  up to 3 years

• Phase 1b: Incidence of clinically significant laboratory abnormalities

  Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in expansion is tolerable

  up to 3 years

• Phase 1b: Incidence of clinically significant ECG abnormalities

  Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in expansion is tolerable

  up to 3 years

Secondary Outcomes (7)

• Phase 1a and 1b: area under the curve

  6 months

• Phase 1a and 1b: maximum concentration

  6 months

• Phase 1a and 1b: time of maximum concentration

  6 months

• Phase 1a and 1b: minimum concentration

  6 months

• Phase 1a and 1b: Molecular response (MR)

  up to 3 years

Study Arms (3)

Phase 1a Dose Escalation

EXPERIMENTAL

ELVN-001 administered in 3+3 dose escalation

Drug: ELVN-001

Phase 1b Dose Expansion (non-T315I)

EXPERIMENTAL

ELVN-001 administered at one or more recommended dose(s) for expansion in CML without T315I mutations

Drug: ELVN-001

Phase 1b expansion (T315I)

EXPERIMENTAL

ELVN-001 administered at the recommended dose for expansion for CML with T315I mutation

Drug: ELVN-001

Interventions

ELVN-001 DRUG

orally once or twice daily

Phase 1a Dose Escalation; Phase 1b Dose Expansion (non-T315I); Phase 1b expansion (T315I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.
• QTc \>470 ms.

Sponsors & Collaborators

• Enliven Therapeutics: lead

Study Sites (45)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Oregon Health & Science University-Knight Cardiovascular Institute

Portland, Oregon, 97239, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Royal Adelaide Hospital

Adelaide, SA 5000, Australia

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

CHU Liege

Liège, 4000, Belgium

RECRUITING

University Health Network (UHN) - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CHU Amiens Picardie Site Sud

Amiens, 80054, France

RECRUITING

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

Bordeaux, 33076, France

RECRUITING

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

Lille, 59000, France

RECRUITING

Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

Limoges, 87000, France

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

WITHDRAWN

Uniklinik RWTH Aachen Medizinische

Aachen, 52074, Germany

RECRUITING

Charite Campus Virchow

Berlin, 13353, Germany

RECRUITING

Klinikum der Goethe Universitat

Frankfurt, 60596, Germany

RECRUITING

Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

Homburg, 66421, Germany

RECRUITING

Universitaetsklinikum Jena

Jena, 07747, Germany

RECRUITING

Medizinische Universitatsklinik Mannheim der Universitat Heidelberg

Mannheim, 68167, Germany

RECRUITING

Universitaetsmedizin Rostock

Rostock, 18057, Germany

RECRUITING

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

Budapest, 1083, Hungary

RECRUITING

Pecsi Tudomanyegyetem Klinikai Kozpont (University of Pecs, Clinical Centre)

Pécs, 7624, Hungary

RECRUITING

Hadassah Medical Center

Jerusalem, 9112001, Israel

RECRUITING

The Galilee Medical Center

Nahariya, 2210001, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Azienda Ospedaliero Universitaria Delle Marche

Ancona, 60126, Italy

RECRUITING

Radboud University Medical Center

Nijmegen, 6525, Netherlands

RECRUITING

Szpital Specjalistycnzy im. Jedrzeja Sniadeckiego w Nowym Saczu

Nowy Sącz, 33-300, Poland

RECRUITING

MICS Centrum Medyczne Torun

Torun, 87-100, Poland

RECRUITING

Instytut Hematologii I Transfuzjologii

Warsaw, 02-776, Poland

RECRUITING

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

WITHDRAWN

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

WITHDRAWN

Uijeongbu Eulji Medical Center

Gyeonggi-do, 11749, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

WITHDRAWN

Samsung Medical Center

Seoul, 06351, South Korea

WITHDRAWN

Hospital Del Mar

Barcelona, 08003, Spain

RECRUITING

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

Las Palmas de Gran Canaria, 35010, Spain

WITHDRAWN

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Complejo Hospitalario de Toledo - Hospital Virgen de la Salud

Toledo, 45007, Spain

TERMINATED

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

Valencia, 46026, Spain

RECRUITING

Beatson West of Scotland Cancer Centre, Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

RECRUITING

Hammersmith Hospital Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Study Contact

CONTACT

707-799-3272; ELVN-001-101@enliventherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 31, 2022
• Study Start: May 22, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7); US (4); CA (1); ES (5); HU (2); GB (3); PL (3); IT (1); NL (1); FR (6); BE (3); AU (1); KR (5); IL (3)