Actively Recruiting
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
Led by Enliven Therapeutics ยท Updated on 2026-04-01
250
Participants Needed
45
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ELVN-001, an investigational drug, in adults with chronic myeloid leukemia (CML), including those with a specific T315I mutation. This early-phase trial aims to find safe and tolerable doses for further study, especially in patients who have relapsed, are resistant, or cannot tolerate current tyrosine kinase inhibitors (TKIs). The study also examines how ELVN-001 affects disease markers and its overall safety profile. The trial includes a dose escalation phase to identify recommended doses, followed by dose expansion phases that treat patients with or without the T315I mutation at those doses. ELVN-001 is given orally once or twice daily. Participants receive the drug as a single agent, and the study monitors responses and safety during these phases. Participants will undergo regular assessments including monitoring for side effects, laboratory tests, heart evaluations, and measurement of molecular responses related to CML over periods ranging from 28 days up to 3 years. The study tracks drug levels in the body for up to 6 months and evaluates long-term outcomes such as complete blood responses. Overall participation duration varies, with close safety follow-up throughout.
CONDITIONS
Brief Title
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BCR-ABL1 positive chronic myeloid leukemia in chronic phase, with or without T315I mutation
- Failed or intolerant to at least one prior second-generation tyrosine kinase inhibitor or asciminib (US criteria)
- Failed, intolerant to, or not a candidate for available therapies active for CML (Rest of World criteria)
- ECOG performance status of 0 to 2
- Adequate hematologic, liver, and kidney function
- Prior bone marrow transplant allowed if at least 6 months before first dose of ELVN-001
You will not qualify if you...
- Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer
- History of acute TKI-related pancreatitis within 6 months
- Active chronic pancreatitis or pancreatic disease from any cause
- QTc interval greater than 470 milliseconds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive ELVN-001 orally once or twice daily as part of a dose escalation or dose expansion to evaluate safety, tolerability, and preliminary anti-CML activity.
Regular visits during treatment period as per protocol
Trial Site Locations
Total: 45 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
3
Oregon Health & Science University-Knight Cardiovascular Institute
Portland, Oregon, United States, 97239
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
Royal Adelaide Hospital
Adelaide, Australia, SA 5000
Actively Recruiting
6
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
7
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
8
CHU Liege
Liรจge, Belgium, 4000
Actively Recruiting
9
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
10
CHU Amiens Picardie Site Sud
Amiens, France, 80054
Actively Recruiting
11
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, France, 33076
Actively Recruiting
12
CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
Lille, France, 59000
Actively Recruiting
13
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
Limoges, France, 87000
Actively Recruiting
14
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
15
Centre Hospitalier Lyon Sud
Pierre-Bรฉnite, France, 69495
Withdrawn
16
Uniklinik RWTH Aachen Medizinische
Aachen, Germany, 52074
Actively Recruiting
17
Charite Campus Virchow
Berlin, Germany, 13353
Actively Recruiting
18
Klinikum der Goethe Universitat
Frankfurt, Germany, 60596
Actively Recruiting
19
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
Homburg, Germany, 66421
Actively Recruiting
20
Universitaetsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
21
Medizinische Universitatsklinik Mannheim der Universitat Heidelberg
Mannheim, Germany, 68167
Actively Recruiting
22
Universitaetsmedizin Rostock
Rostock, Germany, 18057
Actively Recruiting
23
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, Hungary, 1083
Actively Recruiting
24
Pecsi Tudomanyegyetem Klinikai Kozpont (University of Pecs, Clinical Centre)
Pรฉcs, Hungary, 7624
Actively Recruiting
25
Hadassah Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
26
The Galilee Medical Center
Nahariya, Israel, 2210001
Actively Recruiting
27
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
28
Azienda Ospedaliero Universitaria Delle Marche
Ancona, Italy, 60126
Actively Recruiting
29
Radboud University Medical Center
Nijmegen, Netherlands, 6525
Actively Recruiting
30
Szpital Specjalistycnzy im. Jedrzeja Sniadeckiego w Nowym Saczu
Nowy Sฤ cz, Poland, 33-300
Actively Recruiting
31
MICS Centrum Medyczne Torun
Torun, Poland, 87-100
Actively Recruiting
32
Instytut Hematologii I Transfuzjologii
Warsaw, Poland, 02-776
Actively Recruiting
33
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907
Withdrawn
34
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601
Withdrawn
35
Uijeongbu Eulji Medical Center
Gyeonggi-do, South Korea, 11749
Actively Recruiting
36
Chonnam National University Hwasun Hospital
Hwasun, South Korea, 58128
Withdrawn
37
Samsung Medical Center
Seoul, South Korea, 06351
Withdrawn
38
Hospital Del Mar
Barcelona, Spain, 08003
Actively Recruiting
39
Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario e Salud (SCS)
Las Palmas de Gran Canaria, Spain, 35010
Withdrawn
40
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
41
Complejo Hospitalario de Toledo - Hospital Virgen de la Salud
Toledo, Spain, 45007
Terminated
42
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, Spain, 46026
Actively Recruiting
43
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
44
Hammersmith Hospital Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Actively Recruiting
45
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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