NCT06787144RecruitingPhase 1
ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
Source: ClinicalTrials.gov · Last updated 1 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 16 Dec 2024
- Start date
- 23 Jan 2025
- Primary completion date
- Jan 2028
- Lead sponsor
- Enliven Therapeutics
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT06787144
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 21
- From 23 Jan 2025 to the primary completion date, Jan 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
Other illness
- 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.
Lab values
- QTc \>470 ms.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akita University Hospital Coordinator of this site? Confirm its status | Akita | Japan | Recruiting |
| Aiiku Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Recruiting |
| The University of Osaka Hospital Coordinator of this site? Confirm its status | Suita-shi | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.