NCT06787144 ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
| NCT ID | NCT06787144 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Enliven Therapeutics |
| Condition | CML (Chronic Myelogenous Leukemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2028-01 |
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 21 participants in total. It began in 2025-01-23 with a primary completion date of 2028-01.
⚠ 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 Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
Eligibility Criteria
Inclusion Criteria: * BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs. * ECOG performance status of 0 to 2. * The patient was born in Japan and both parents and grandparents are Japanese. * 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
Helen Collins, MD
STUDY DIRECTOR
Enliven Therapeutics
Frequently Asked Questions
Who can join the NCT06787144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CML (Chronic Myelogenous 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 NCT06787144 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 NCT06787144 currently recruiting?
Yes, NCT06787144 is actively recruiting participants. Contact the research team at ClinicalTrialInformation@cmic.co.jp for enrollment information.
Where is the NCT06787144 trial being conducted?
This trial is being conducted at Akita, Japan, Sapporo, Japan, Suita-shi, Japan, Shinjuku-ku, Japan.
Who is sponsoring the NCT06787144 clinical trial?
NCT06787144 is sponsored by Enliven Therapeutics. The principal investigator is Helen Collins, MD at Enliven Therapeutics. The trial plans to enroll 21 participants.
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