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

ConditionsCML (Chronic Myelogenous Leukemia)Chronic Phase CML
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEnliven Therapeutics

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ELVN-001

    Drug

    Orally once or twice daily

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: Part 1 Dose EscalationExperimental treatment 1 intervention
Group B: Part 2 Dose ExplorationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Incidence of dose limiting toxicities

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

Time frame
28 days
2

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

Time frame
Up to 28 days
3

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

Time frame
Up to 28 days
4

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

Time frame
Up to 28 days

Secondary outcomes

1

Area under the curve

PK parameter based on measurement of drug concentration in blood over time

Time frame
6 months
2

Maximum concentration

PK parameter based on measurement of drug concentration in blood

Time frame
6 months
3

Time of maximum concentration

PK parameter which is the time at which the highest concentration of drug in the blood is measured

Time frame
6 months
4

Minimum concentration

PK parameter based on the measurement of the drug concentration that is at the lowest level once steady state has been achieved.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Enliven Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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