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Recruiting NCT05304377

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

Phase I Interventional Chronic Myeloid Leukemia Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive Cml

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ELVN-001.
Who it may be relevant to
Registry conditions: Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Cml. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, Canada, France +9
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Interventions

  • Drug ELVN-001
    orally once or twice daily

Primary outcome measures

  • Phase 1a: Incidence of dose limiting toxicities [Time frame: 28 days]
  • Phase 1a: Incidence of adverse events (AEs) [Time frame: up to 28 days]
  • Phase 1a: Incidence of clinically significant laboratory abnormalities [Time frame: up to 28 days]
  • Phase 1a: Incidence of clinically significant ECG abnormalities [Time frame: up to 28 days]
  • Phase 1b: Incidence of adverse events [Time frame: up to 3 years]
  • Phase 1b: Incidence of clinically significant laboratory abnormalities [Time frame: up to 3 years]
  • Phase 1b: Incidence of clinically significant ECG abnormalities [Time frame: up to 3 years]
Secondary outcome measures (7)
  • Phase 1a and 1b: area under the curve [Time frame: 6 months]
  • Phase 1a and 1b: maximum concentration [Time frame: 6 months]
  • Phase 1a and 1b: time of maximum concentration [Time frame: 6 months]
  • Phase 1a and 1b: minimum concentration [Time frame: 6 months]
  • Phase 1a and 1b: Molecular response (MR) [Time frame: up to 3 years]
  • Phase 1b: Duration of Molecular Response [Time frame: up to 3 years]
  • Phase 1b: Complete Hematologic Response (CHR) [Time frame: up to 3 years]

Eligibility criteria

Inclusion criteria

  • 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 7 centers
  • Uniklinik RWTH Aachen Medizinische — Aachen
  • Charite Campus Virchow — Berlin
  • Klinikum der Goethe Universitat — Frankfurt
  • Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarl — Homburg
  • Universitaetsklinikum Jena — Jena
  • Medizinische Universitatsklinik Mannheim der Universitat Heidelberg — Mannheim
  • Universitaetsmedizin Rostock — Rostock
France · 6 centers
  • CHU Amiens Picardie Site Sud — Amiens
  • Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux
  • CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille — Lille
  • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren — Limoges
  • Centre Leon Berard — Lyon
  • Centre Hospitalier Lyon Sud — Pierre-Bénite
South Korea · 5 centers
  • Chonbuk National University Hospital — Jeonju
  • Keimyung University Dongsan Hospital — Daegu
  • Uijeongbu Eulji Medical Center — Gyeonggi-do
  • Chonnam National University Hwasun Hospital — Hwasun
  • Samsung Medical Center — Seoul
Spain · 5 centers
  • Hospital Del Mar — Barcelona
  • Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario e Salud (SCS) — Las Palmas de Gran Canaria
  • Hospital Universitario La Paz — Madrid
  • Complejo Hospitalario de Toledo - Hospital Virgen de la Salud — Toledo
  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital L — Valencia
United States · 4 centers
  • Memorial Sloan Kettering Cancer Center — New York
  • Montefiore Medical Center — The Bronx
  • Oregon Health & Science University-Knight Cardiovascular Institute — Portland
  • The University of Texas MD Anderson Cancer Center — Houston
Belgium · 3 centers
  • UZ Gent — Ghent
  • UZ Leuven — Leuven
  • CHU Liege — Liège
Israel · 3 centers
  • Hadassah Medical Center — Jerusalem
  • The Galilee Medical Center — Nahariya
  • Rabin Medical Center — Petah Tikva
Poland · 3 centers
  • Szpital Specjalistycnzy im. Jedrzeja Sniadeckiego w Nowym Saczu — Nowy Sącz
  • MICS Centrum Medyczne Torun — Torun
  • Instytut Hematologii I Transfuzjologii — Warsaw
United Kingdom · 3 centers
  • Beatson West of Scotland Cancer Centre, Gartnavel General Hospital — Glasgow
  • Hammersmith Hospital Imperial College Healthcare NHS Trust — London
  • The Christie NHS Foundation Trust — Manchester
Hungary · 2 centers
  • Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika — Budapest
  • Pecsi Tudomanyegyetem Klinikai Kozpont (University of Pecs, Clinical Centre) — Pécs
Australia · 1 center
  • Royal Adelaide Hospital — Adelaide
Canada · 1 center
  • University Health Network (UHN) - Princess Margaret Cancer Centre — Toronto
Italy · 1 center
  • Azienda Ospedaliero Universitaria Delle Marche — Ancona
Netherlands · 1 center
  • Radboud University Medical Center — Nijmegen

Identifiers

NCT: NCT05304377 · ELVN-001-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗