ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants

NCT ID: NCT06787144

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-23
• Study Completion Date: 2028-01-31

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.

Detailed Description

This first-in-human trial with ELVN-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (RDEs) of single agent ELVN-001 in chronic phase CML with or without T315I mutations. The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed together with an evaluation of changes in BCR-ABL1 transcript. An understanding of the safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development of ELVN-001 in adults with CML. By virtue of its predicted pharmacological profile ELVN-001 has the potential to be tolerable and achieve a deep molecular response in patients with CML with or without T315I mutations who have failed, or are intolerant to, or not a candidate for, at least 2 prior TKIs.

Conditions

CML (Chronic Myelogenous Leukemia); Chronic Phase CML

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 Dose Escalation

ELVN-001 administered in 3+3 dose escalation

Group Type: EXPERIMENTAL

ELVN-001

Intervention Type: DRUG

Orally once or twice daily

Part 2 Dose Exploration

ELVN-001 administered to approximately 6 participants per dose level who may be enrolled at or below the dose levels that have been deemed safe and tolerable in Part 1

Group Type: EXPERIMENTAL

ELVN-001

Intervention Type: DRUG

Orally once or twice daily

Interventions

ELVN-001

Orally once or twice daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enliven Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Collins, MD

Role: STUDY_DIRECTOR

Enliven Therapeutics

Locations

Akita University Hospital

Akita, Akita, Japan

Site Status: RECRUITING

Aiiku Hospital

Sapporo, Hokkaido, Japan

Site Status: RECRUITING

The University of Osaka Hospital

Suita-shi, Osaka, Japan

Site Status: RECRUITING

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Yuzo Tomonaga

Role: CONTACT

ClinicalTrialInformation@cmic.co.jp

+81-3-6779-8000

Facility Contacts

Yuzo Tomonaga

Role: primary

+81-3-6779-8000

Yuzo Tomonaga

Role: primary

+81-3-6779-8000

Yuzo Tomonaga

Role: primary

+81-3-6779-8000

Yuzo Tomonaga

Role: primary

+81-3-6779-8000

Other Identifiers

ELVN-001-105

Identifier Type: -

Identifier Source: org_study_id