Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05304377 · ClinicalTrials.gov registry record · Phase 1
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
A Phase 1 study of Chronic Myeloid Leukemia and CML, sponsored by Enliven Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT05304377: Recruiting Phase 1 study of Chronic Myeloid Leukemia and CML, sponsored by Enliven Therapeutics.
NCT05304377 is a Phase 1 study of Chronic Myeloid Leukemia and CML that is actively recruiting participants, run by Enliven Therapeutics. The registered enrollment target is 200 participants, roughly in line with the 204-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05304377, a Phase 1 study of Chronic Myeloid Leukemia and CML, is actively recruiting participants, sponsored by Enliven Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
DLTs will be used to support that the recommended doses for expansion are \</= MTD
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 |
What NCT05304377 shows while recruiting
NCT05304377 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 204-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target.
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.
NCT05304377 names 20 study sites across 5 states, led by Other, New York, Oregon.
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, CML, Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive.
What interventions are being tested in trial NCT05304377?
The interventions under investigation include: ELVN-001 (DRUG).
Who is sponsoring clinical trial NCT05304377?
This trial is sponsored by Enliven Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Chronic Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05304377's enrollment target sits among peer trials
200 8th of 35 higher than 28 of 35 other Chronic Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
RECRUITING · Phase 1
-
KRT-232 and TKI Study in Chronic Myeloid Leukemia
RECRUITING · Phase 1
-
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
RECRUITING · Phase 1
-
Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
RECRUITING · Phase 1
-
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 · Phase 1
-
A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI