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

NCT06787144 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ELVN-001-105
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

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.

Conditions

CML (Chronic Myelogenous Leukemia); Chronic Phase CML

Keywords

CML; Tyrosine Kinase Inhibitor; T315I; T315I Mutant; BCR-ABL

Outcome Measures

Primary Outcomes (7)

• Part 1: Incidence of dose limiting toxicities

  DLTs will be used to support that the recommended doses for expansion are \</= MTD

  28 days

• Part 1: Incidence of adverse events (AEs)

  Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable

  Up to 28 days

• Part 1: Incidence of clinically significant laboratory abnormalities

  Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

  Up to 28 days

• Part 1: Incidence of clinically significant ECG abnormalities

  Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

  Up to 28 days

• Part 2: Incidence of adverse events

  Adverse events will be used to support that the dose(s) evaluated in exploration is tolerable

  Up to 3 years

• Part 2: Incidence of clinically significant laboratory abnormalities

  Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in exploration is tolerable

  Up to 3 years

• Part 2: Incidence of clinically significant ECG abnormalities

  Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in exploration is tolerable

  Up to 3 years

Secondary Outcomes (7)

• Area under the curve

  6 months

• Maximum concentration

  6 months

• Time of maximum concentration

  6 months

• Minimum concentration

  6 months

• Molecular response (MR)

  Up to 3 years

Study Arms (2)

Part 1 Dose Escalation

EXPERIMENTAL

ELVN-001 administered in 3+3 dose escalation

Drug: ELVN-001

Part 2 Dose Exploration

EXPERIMENTAL

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

Drug: ELVN-001

Interventions

ELVN-001 DRUG

Orally once or twice daily

Part 1 Dose Escalation; Part 2 Dose Exploration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enliven Therapeutics: lead

Study Sites (4)

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

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helen Collins, MD

  Enliven Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Yuzo Tomonaga

CONTACT

+81-3-6779-8000; ClinicalTrialInformation@cmic.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 22, 2025
• Study Start: January 23, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)