NCT05304377 A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
| NCT ID | NCT05304377 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Enliven Therapeutics |
| Condition | Chronic Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-05-22 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 250 participants in total. It began in 2022-05-22 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05304377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05304377 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05304377 currently recruiting?
Yes, NCT05304377 is actively recruiting participants. Contact the research team at ELVN-001-101@enliventherapeutics.com for enrollment information.
Where is the NCT05304377 trial being conducted?
This trial is being conducted at New York, United States, The Bronx, United States, Portland, United States, Houston, United States and 11 additional locations.
Who is sponsoring the NCT05304377 clinical trial?
NCT05304377 is sponsored by Enliven Therapeutics. The trial plans to enroll 250 participants.
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