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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

- The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML.

- ECOG performance status of 0 to 2.

- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05304377
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Enliven Therapeutics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Canada, France, Germany, Korea, Republic of, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Myeloid Leukemia

Additional Details

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 do not tolerate or benefit from available TKIs.

Arms & Interventions

Arms

Experimental: Phase 1a Dose Escalation

ELVN-001 administered in 3+3 dose escalation

Experimental: Phase 1b Dose Expansion at recommended dose level 1

ELVN-001 administered at the recommended dose in CML without T315I mutations

Experimental: Phase 1b Dose Expansion at recommended dose level 2

ELVN-001 administered at a different recommended dose in CML without T315I mutations

Experimental: Phase 1b expansion arm in T315I mutated CML

ELVN-001 administered at the recommended dose for CML with T315I mutation

Interventions

Drug: - ELVN-001

orally once or twice daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Michael Mauro, MD

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