Clinical trial NCT06787144: ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
Official title: A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: CML (Chronic Myelogenous Leukemia)
Chronic Phase CML
Keywords: CML
Tyrosine Kinase Inhibitor
T315I
T315I Mutant
BCR-ABL
Lead sponsor: Enliven Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-01-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Part 1: Incidence of dose limiting toxicities
timeFrame: 28 days
measure: Part 1: Incidence of adverse events (AEs)
timeFrame: Up to 28 days
measure: Part 1: Incidence of clinically significant laboratory abnormalities
timeFrame: Up to 28 days
measure: Part 1: Incidence of clinically significant ECG abnormalities
timeFrame: Up to 28 days
measure: Part 2: Incidence of adverse events
timeFrame: Up to 3 years
measure: Part 2: Incidence of clinically significant laboratory abnormalities
timeFrame: Up to 3 years
measure: Part 2: Incidence of clinically significant ECG abnormalities
timeFrame: Up to 3 years
Secondary outcomes:
measure: Area under the curve
timeFrame: 6 months
measure: Maximum concentration
timeFrame: 6 months
measure: Time of maximum concentration
timeFrame: 6 months
measure: Minimum concentration
timeFrame: 6 months
measure: Molecular response (MR)
timeFrame: Up to 3 years
measure: Duration of Molecular Response
timeFrame: Up to 3 years
measure: Complete Hematologic Response (CHR)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Akita-shi
country: Japan
facility: Akita University Hospital
state: Akita-ken
city: Sapporo
country: Japan
facility: Aiiku Hospital
state: Hokkaido
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
Study officials:
affiliation: Enliven Therapeutics
name: Helen Collins, MD
role: STUDY_DIRECTOR
References: