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A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
NCT05304377 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG ELVN-001
Study Locations (20)
Other
- Royal Adelaide Hospital — Adelaide
- UZ Gent — Ghent
- UZ Leuven — Leuven
- CHU Liege — Liège
- CHU Amiens Picardie Site Sud — Amiens
- Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux
- Centre Hospitalier de Versailles (CHV) — Le Chesnay
- 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
- Uniklinik RWTH Aachen Medizinische — Aachen
- Charite Campus Virchow — Berlin
- Klinikum der Goethe Universitat — Frankfurt
- Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes — Homburg
New York
- Memorial Sloan Kettering Cancer Center — New York
- Montefiore Medical Center — The Bronx
Oregon
- Oregon Health & Science University-Knight Cardiovascular Institute — Portland
Texas
- The University of Texas MD Anderson Cancer Center — Houston
Ontario
- University Health Network (UHN) - Princess Margaret Cancer Centre — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-05-22 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05304377
The ClinicalTrials.gov registry entry for NCT05304377 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Enliven Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention — of which ELVN-001 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05304377 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, New York, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05304377 about?
NCT05304377 is a clinical study titled "A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia". 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.
What is the current status of trial NCT05304377?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2022-05-22. Estimated completion is 2026-12.
What conditions does trial NCT05304377 study?
This clinical trial studies the following conditions: Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Cml. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05304377?
The interventions under investigation include: ELVN-001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05304377?
This trial is sponsored by Enliven Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05304377 being conducted?
This trial has 20 study locations across New York, Oregon, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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