RecruitingPhase 1NCT06787144

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


Sponsor

Enliven Therapeutics

Enrollment

21 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ELVN-001 for people with a type of blood cancer called chronic myeloid leukemia (CML) — a cancer where the bone marrow makes too many abnormal white blood cells. The study is specifically for Japanese patients whose CML has stopped responding to earlier treatments. **You may be eligible if...** - You have been diagnosed with a specific form of CML (BCR::ABL1-positive, chronic phase) - At least 2 prior CML medications (called TKIs or tyrosine kinase inhibitors) have not worked for you, you could not tolerate them, or you are not a candidate for them - You were born in Japan and all four of your grandparents are Japanese - You are reasonably fit and able to carry out daily activities (ECOG 0-2) - Your blood, liver, and kidney function are adequate - If you had a bone marrow transplant, it was at least 6 months ago **You may NOT be eligible if...** - You received cancer treatment within the past 7 days (or within 5 half-lives of the drug) - You have a history of severe pancreatitis (pancreas inflammation) caused by a TKI drug in the last 6 months, or you have active chronic pancreatitis - Your heart has an abnormal electrical pattern (prolonged QTc interval over 470 ms on an ECG) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGELVN-001

Orally once or twice daily


Locations(4)

Akita University Hospital

Akita, Akita, Japan

Aiiku Hospital

Sapporo, Hokkaido, Japan

The University of Osaka Hospital

Suita-shi, Osaka, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT06787144


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