RecruitingPHASE1INTERVENTIONAL

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

This study is investigating a new medication, ELVN-001, for adults living with Chronic Myeloid Leukaemia (CML). CML is a type of blood cancer. This first-stage study wants to find the safest and most effective dose of ELVN-001. Researchers will also be looking closely at any side effects and how well the medicine works, particularly for patients whose CML hasn't responded to previous treatments, or if those treatments caused difficult side effects. The goal is to understand if ELVN-001 could be a good new option for CML patients in the future, helping them achieve better results and a good quality of life.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Enliven Therapeutics

Enrolment target

250

Start

22 May 2022

Estimated completion

01 Dec 2027

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

What is this study about?

This study is about a new medicine called ELVN-001, which is being tested in people with Chronic Myeloid Leukaemia (CML). CML is a slow-growing cancer of the blood and bone marrow. The main purpose of this early-stage study is to understand more about ELVN-001 – for example, what is the best dose to give, how safe it is, and if it causes any side effects. Researchers will also look at how the body handles the medicine and if it shows early signs of helping to control CML.

ELVN-001 is being developed for people with CML, especially those who haven't responded well to other common CML treatments called TKIs, or who have found the side effects of those treatments too difficult to manage. Some people with CML also have a specific change in their cancer cells (called a T315I mutation) that can make their CML harder to treat; this study includes people with and without this mutation.

The hope is that ELVN-001 could offer a new and effective treatment option. The collected information will be used to help researchers decide if ELVN-001 should be studied in larger groups of people and potentially become a new treatment available for CML patients in the future.

Key takeaways

This is an early-stage study for a new CML medicine called ELVN-001.
It's for adults with CML who haven't responded well to other treatments or had bad side effects.
The study aims to find the right dose, check safety, and see if it helps control CML.
You'll be closely monitored by a medical team.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, adult patients must have a specific type of CML called "chronic phase" CML. Your CML cells must also have a specific genetic marker called BCR-ABL1. It's okay if you also have the T315I mutation.

Importantly, your current CML treatments must not be working well for you, or you must have found them too difficult to tolerate due to side effects. For patients in the UK and other parts of the world, this means you've either tried and failed at least one other type of CML medication (specifically a 'second-generation TKI' or asciminib), or that other available treatments for your CML aren't suitable for you. You also need to be generally well enough to take part and not have certain other health issues.

There are also some reasons why you might not be able to join. For example, if you've recently had other anti-cancer treatments, or if you have a history of certain heart or pancreas problems. The study doctors will carefully check all your health details to make sure the study is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or over?
Do you have Chronic Myeloid Leukaemia (CML) in its 'chronic phase'?
Has your CML not responded well to at least one previous TKI treatment, or did you have difficult side effects from it?
Are you generally well and able to carry out your daily activities?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive doses of the new medicine, ELVN-001. This is a "dose escalation" study, which means that different groups of people will receive carefully increasing doses of the medicine to find the safest and most effective amount. You will have regular appointments with the study team for blood tests, physical exams, and other checks to see how you are doing and how the medicine is affecting your body and your CML.

The study team will carefully monitor your health for any side effects and how well the treatment is working. This will involve closely looking at your CML cells to see if the medicine is reducing the number of cancer cells. The total length of your participation will depend on how you respond to the treatment and the study plan, but you will have ongoing support and monitoring throughout.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A possible benefit is that ELVN-001 might help control your CML, especially if other treatments haven't worked well for you. It's important to remember that this is a new medicine and its full effects are still being understood. Potential risks include experiencing side effects from the medication. The study team will explain all known and possible side effects to you before you decide to join. Your safety is their top priority, and you will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (45)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Montefiore Medical Center
Verified postcode
The Bronx, United States· Recruiting
Oregon Health & Science University-Knight Cardiovascular Institute
Verified postcode
Portland, United States· Recruiting
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Royal Adelaide Hospital
Verified postcode
Adelaide, Australia· Recruiting
UZ Gent
Verified postcode
Ghent, Belgium· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
CHU Liege
Verified postcode
Liège, Belgium· Recruiting
University Health Network (UHN) - Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting
CHU Amiens Picardie Site Sud
Verified postcode
Amiens, France· Recruiting
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Verified postcode
Bordeaux, France· Recruiting
CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
Verified postcode
Lille, France· Recruiting

Common questions

What is CML?

CML stands for Chronic Myeloid Leukaemia. It's a type of cancer that starts in the blood-forming cells of the bone marrow.

What does 'TKI' mean?

TKI stands for Tyrosine Kinase Inhibitor. These are a common type of medicine used to treat CML.

What is a 'first-in-human' trial?

This means it's one of the first times this new medicine, ELVN-001, is being given to people. It's an important early step in testing new treatments.

Will I know if I'm getting the active drug?

Yes, in this type of study, all participants receive the active drug, ELVN-001, at different doses.

How long will my participation last?

The exact duration will depend on your individual response and the study doctor's plan, but you will be monitored throughout your time on the trial.

How to find out more

Study Contact

ELVN-001-101@enliventherapeutics.com 707-799-3272 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.