Treatment of Chronic Myeloid Leukemia with ELVN-001 in Japanese Patients
A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
This study is testing a new treatment called ELVN-001 for Japanese patients with chronic myeloid leukemia who haven't had success with other medications to see if it's safe and effective.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Enliven Therapeutics Industry-sponsored |
| Locations | 4 sites (Akita, Akita and 3 other locations) |
| Trial ID | NCT06787144 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of ELVN-001, a new treatment for chronic myeloid leukemia (CML), in Japanese patients who have not responded to or cannot tolerate at least two prior tyrosine kinase inhibitors (TKIs). It is a first-in-human, dose escalation study aimed at determining the recommended dose for further evaluation. The study will also assess the pharmacokinetics and anti-CML activity of ELVN-001, particularly in patients with or without the T315I mutation. The findings will inform future development of this treatment for adults with CML.
Who should consider this trial
Good fit: Ideal candidates are Japanese patients with chronic phase CML who have failed or are intolerant to at least two prior TKIs.
Not a fit: Patients currently receiving anti-cancer therapy or those with certain pancreatic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with chronic myeloid leukemia who have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar studies targeting CML have shown promise in developing new treatments.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Akita, Akita and 3 other locations
- Akita University Hospital — Akita, Akita, Japan (Recruiting)
- Aiiku Hospital — Sapporo, Hokkaido, Japan (Recruiting)
- The University of Osaka Hospital — Suita-shi, Osaka, Japan (Recruiting)
- Tokyo Medical University Hospital — Shinjuku-ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Yuzo Tomonaga
- Email: ClinicalTrialInformation@cmic.co.jp
- Phone: +81-3-6779-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.