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

Description

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.

Conditions

Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Cml

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Portland

Oregon Health & Science University-Knight Cardiovascular Institute, Portland, Oregon, United States, 97239

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Enliven Therapeutics,

Study Record Dates

2026-12