Clinical Trials in Japan / NCT06787144
Recruiting
Phase 1
ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
NCT06787144 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
CML (Chronic Myelogenous Leukemia)Chronic Phase CML
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 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
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.
Primary outcome measure(s)
- Part 1: Incidence of dose limiting toxicities — 28 days
DLTs will be used to support that the recommended doses for expansion are \</= MTD - Part 1: Incidence of adverse events (AEs) — Up to 28 days
Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable - Part 1: Incidence of clinically significant laboratory abnormalities — Up to 28 days
Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable - Part 1: Incidence of clinically significant ECG abnormalities — Up to 28 days
Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable - Part 2: Incidence of adverse events — Up to 3 years
Adverse events will be used to support that the dose(s) evaluated in exploration is tolerable - Part 2: Incidence of clinically significant laboratory abnormalities — Up to 3 years
Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in exploration is tolerable - Part 2: Incidence of clinically significant ECG abnormalities — Up to 3 years
Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in exploration is tolerable
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Akita University Hospital | Akita | Akita | Recruiting |
| Aiiku Hospital | Sapporo | Hokkaido | Recruiting |
| The University of Osaka Hospital | Suita-shi | Osaka | Recruiting |
| Tokyo Medical University Hospital | Shinjuku-ku | Tokyo | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06787144 on ClinicalTrials.gov ↗ ← All trials in Japan