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Clinical Trials in Spain / NCT05304377
Recruiting Phase 1

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

NCT05304377 · tracked via the Priya Life Science Spain tracker
Sponsor
Enliven Therapeutics
Phase
Phase 1
Started
2022-05-22
Last updated
2026-04-01

Condition(s) studied

Chronic Myeloid LeukemiaChronic Phase Chronic Myeloid Leukemia, BCR-ABL1 PositiveCml

Investigational drug(s) / intervention(s)

ELVN-001 →

ELVN-001: orally once or twice daily

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Phase 1a: Incidence of dose limiting toxicities — 28 days
    DLTs will be used to support that the recommended doses for expansion are \</= MTD
  • Phase 1a: Incidence of adverse events (AEs) — up to 28 days
    Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable
  • Phase 1a: Incidence of clinically significant laboratory abnormalities — up to 28 days
    Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
  • Phase 1a: Incidence of clinically significant ECG abnormalities — up to 28 days
    Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
  • Phase 1b: Incidence of adverse events — up to 3 years
    Adverse events will be used to support that the dose(s) evaluated in expansion is tolerable
  • Phase 1b: Incidence of clinically significant laboratory abnormalities — up to 3 years
    Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in expansion is tolerable
  • Phase 1b: Incidence of clinically significant ECG abnormalities — up to 3 years
    Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in expansion is tolerable

Trial sites (45)

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

+ 5 more sites — see the full list on the official registry below.

More Enliven Therapeutics trials in Spain

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer Active, not recruiting
ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer Active, not recruiting

Other trials for the same condition

A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL) Recruiting
Study of Olverembatinib (HQP1351) in Patients With CML-CP Recruiting
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML Recruiting
International Chronic Myeloid Leukemia Pediatric Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05304377 on ClinicalTrials.gov ↗ ← All trials in Spain