At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- ELVN-001 (drug)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- ELVN-001 — drug: orally once or twice daily
- Patient visit burden
- Not specified by the sponsor
In plain English
This is an early-stage (Phase 1a/1b) study testing a new drug called ELVN-001 for adults with chronic myeloid leukaemia (CML), a blood cancer, in the chronic phase and positive for BCR-ABL1. The study is funded by Enliven Therapeutics. People with or without a change in their cancer called the T315I mutation may take part.
Who can take part
- Chronic myeloid leukaemia (CML) in chronic phase that is BCR-ABL1 positive, with or without the T315I change.
- In the US: the person has not been helped by, or could not tolerate, at least one earlier second-generation tyrosine kinase inhibitor (a type of cancer medicine) or asciminib. Elsewhere, including the UK: the person has not been helped by, could not tolerate, or cannot take medicines known to work for their CML (rules may differ by country).
- Able to carry out day-to-day activities to a certain level (performance status 0 to 2).
- Good enough blood, liver and kidney function.
- A past bone marrow transplant is allowed if it was at least 6 months before the first dose of ELVN-001.
Who may not be able to
- Cancer or CML treatment within the last 7 days or 5 half-lives of the medicine, whichever is longer.
- A history of sudden (acute) pancreas swelling (pancreatitis) linked to tyrosine kinase inhibitor medicine within 6 months of joining, ongoing long-term pancreatitis, or pancreas problems from any cause.
- A certain heart rhythm reading (QTc) above 470 milliseconds.
What taking part involves
- • Taking an experimental medicine called ELVN-001. Not stated — ask the trial team for details on how it is given or how often.
Time commitment: Not stated — ask the trial team about visit frequency, study length, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 250
- Started
- 2022-05-22
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for chronic myeloid leukemia
- • Phase1 - 250 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic myeloid leukemia
Where?
- • Glasgow - Beatson West of Scotland Cancer Centre, Gartnavel General Hospital
- • London - Hammersmith Hospital Imperial College Healthcare NHS Trust
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
What the study is looking for
- ✓BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.
- ✓Fit enough for normal activity (ECOG 0) to 2.
- ✓Adequate blood, liver and kidney function.
- ✓Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.
Who cannot take part
- ✗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...
- ✗QTc \>470 ms.
See the full criteria
Where Is This Study? (3 UK sites)
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital
Glasgow G12 0YN, United Kingdom
Hammersmith Hospital Imperial College Healthcare NHS Trust
London W12 0HS, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT