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

NCT05304377 · tracked via the Priya Life Science USA 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

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)

Facility	City	Region	Status
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 the USA

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

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer Active, not recruiting

Other trials for the same condition

Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL Recruiting

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias Recruiting

Study of Olverembatinib (HQP1351) in Patients With CML-CP Recruiting

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

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 the USA