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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of ELVN-001 and how well people can handle it, and aims to find a dose for future studies. It is for people with chronic myeloid leukemia (CML), a blood cancer, that came back, did not respond to certain treatments, or whose treatment caused side effects they could not handle.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have chronic-phase CML, a slower-growing phase, with the BCR-ABL1 gene change. People with or without the T315I gene change may join.
  • In the US: At least one newer tyrosine kinase inhibitor (TKI), a targeted cancer drug, or asciminib did not work or caused side effects you could not handle.
  • Outside the US: Available treatments for your CML did not work, caused side effects you could not handle, or are not suitable for you. Rules may vary by country.
  • Can care for yourself and are up and about for at least half of your waking hours (ECOG score 0–2).
  • Have blood counts and liver and kidney function that meet study requirements.
  • A past bone marrow transplant is allowed if it was at least 6 months before the first ELVN-001 dose.

Who can't join

  • Received cancer or CML treatment too recently: within 7 days or the time it takes for the drug level to drop by half five times, whichever is longer.
  • Had sudden swelling of the pancreas linked to a TKI within 6 months before joining, have ongoing long-term swelling of the pancreas, or have pancreatic disease from any cause.
  • Have a QTc above 470 milliseconds, a heart test result showing that the heart takes too long to reset between beats.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. * 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.

Study sites (4)

NY

OR

TX