NCT05304377RecruitingPhase 1
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 15 Mar 2022
- Start date
- 22 May 2022
- Primary completion date
- Dec 2027
- Lead sponsor
- Enliven Therapeutics
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT05304377
- EU CT number
- 2023-503335-18-00
- EudraCT number
- 2022-000052-11
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 250
- From 22 May 2022 to the primary completion date, Dec 2027
- 42 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
Other illness
- 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.
Lab values
- QTc \>470 ms.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (42)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| University Health Network UHN Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Universitaet Des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Universitat Heidelberg Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Hospitalier Et Universitaire de Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Hammersmith Hospital, Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| The Galilee Medical Center Coordinator of this site? Confirm its status | Nahariya | Israel | Recruiting |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Withdrawn |
| Uijeongbu Eulji Medical Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Withdrawn |
| Chonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Withdrawn |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Withdrawn |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ Coordinator of this site? Confirm its status | Nowy Sacz | Poland | Recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| Instytut Hematologii I Transfuzjologii Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Oregon Health & Science University-Knight Cardiovascular Institute Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.