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A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

ConditionsChronic Myeloid LeukemiaChronic Phase Chronic Myeloid Leukemia, BCR-ABL1 PositiveCml
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 patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.

US: The patient has failed or is intolerant to at least one prior second-generation tyrosine kinase inhibitor (TKI) or asciminib. Rest of World: The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML (country-specific criteria may vary).

ECOG performance status of 0 to 2.

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

250 Participants
are divided into 3 treatment groups
Group A: Phase 1a Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1b Dose Expansion (non-T315I)Experimental treatment 1 intervention
Group C: Phase 1b expansion (T315I)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1a: Incidence of dose limiting toxicities

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

Time frame
28 days
2

Phase 1a: 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

Phase 1a: 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

Phase 1a: 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

Phase 1a and 1b: area under the curve

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

Time frame
6 months
2

Phase 1a and 1b: maximum concentration

PK parameter based on measurement of drug concentration in blood

Time frame
6 months
3

Phase 1a and 1b: 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

Phase 1a and 1b: 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

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Enliven Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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