RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of EP0031 in Patients With Advanced RET-altered Malignancies

This research study is looking at a new drug, EP0031, for people with advanced cancers that have a specific genetic change called a RET alteration. These include a type of lung cancer. The main goals are to find out if EP0031 is safe, what side effects it might have, and if it can help treat these cancers. EP0031 is being explored as it might work even when other similar treatments have stopped being effective. The study has two main parts: Phase 1 focused on finding the safest and most effective dose, and Phase 2 will now use that dose to further check how well it works and its safety in more people.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Ellipses Pharma

Enrolment target

265

Start

30 Sep 2022

Estimated completion

01 Jun 2027

Advanced Solid Tumor NSCLC

What is this study about?

This study is investigating a new medicine called EP0031. It's designed for adults who have advanced cancers that are linked to a specific change in a gene called RET. This includes a type of lung cancer known as NSCLC (Non-Small Cell Lung Cancer). Researchers want to understand if EP0031 is safe to use, what kinds of side effects people might experience, and how effective it is at treating these cancers.

Currently, there are some treatments for RET-altered cancers, but sometimes they stop working. Scientists believe that EP0031 might be able to help in these situations. It's thought to be a strong and specific treatment that targets the faulty RET gene, even when the cancer has become resistant to earlier treatments. By taking part, you would be helping medical science learn more about new ways to fight these specific cancers.

The study is split into two phases. The first phase focused on carefully finding the best dose of EP0031 to use. This part is now finished. The second phase, which is ongoing, will use this carefully chosen dose in more people to gather more information about its safety and how well it works. Your participation could contribute significantly to developing new treatment options for future patients.

Key takeaways

This study is testing a new drug, EP0031, for advanced cancers with a RET gene alteration.
It aims to find out if the drug is safe, what side effects it has, and how well it treats cancer.
EP0031 is designed to work even if previous RET treatments haven't succeeded.
You must be 18 or older with a confirmed RET-altered cancer to be considered.
Your general health and other medical conditions will be carefully checked for eligibility.
Participation involves regular check-ups, tests, and taking the study medication.

Who may be eligible?

To join this study, you must be 18 years or older and have a confirmed RET-altered cancer. You should also be generally well enough to take part in the study activities, meaning you can look after yourself most of the time and don't have severe medical issues, such as serious heart problems or active infections requiring strong medication. Important information will be shared with you about other treatment options.

There are also some reasons why you might not be able to join. For example, if your cancer has other major gene changes besides RET, or if you have specific conditions like untreated brain tumours or serious kidney or liver problems. Certain medications or uncontrolled health issues like very high blood pressure could also prevent you from participating.

The doctors will carefully review your medical history and test results to make sure this study is safe and suitable for you. They will explain everything in detail, and you'll have the chance to ask any questions you have.

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 18 years old or older?
Do you have a cancer that has been confirmed to have a 'RET alteration'?
Are you generally able to look after yourself and manage daily activities?
Do you have good kidney and liver function?
Do you not have active serious infections?
Are your heart readings (like an ECG) generally normal?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, EP0031. Doctors and nurses will closely monitor your health to check how the treatment affects you, including looking for any side effects and how well the treatment is working. This will involve regular clinic visits, blood tests, and scans over a period of time. You will need to attend all scheduled appointments and follow the study instructions carefully. The exact number of visits and the total duration of your participation will depend on how you respond to the treatment and what the study doctors determine is best for you.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to receive a new treatment that isn't yet widely available, which could potentially help your condition. However, there are also risks, as new medicines can cause unexpected side effects or might not be effective for everyone. You will be told about all known potential risks and side effects before you decide to join. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

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

David Geffen School of Medicine at UCLA
Verified postcode
Los Angeles, United States· Recruiting
Stanford University
Verified postcode
Stanford, United States· Recruiting
Georgetown University
Verified postcode
Washington D.C., United States· Recruiting
Florida Cancer Specialist
Verified postcode
Fort Myers, United States· Recruiting
RUSH University Medical Center
Verified postcode
Chicago, United States· Terminated
Northwestern University
Verified postcode
Evanston, United States· Recruiting
University of Kentucky
Verified postcode
Lexington, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Karmanos
Verified postcode
Detroit, United States· Terminated
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
NYU Langone Health
Verified postcode
New York, United States· Recruiting
Providence Portland Medical Centre
Verified postcode
Portland, United States· Recruiting

Common questions

What does 'RET-altered malignancies' mean?

This refers to cancers that have a specific change, or 'alteration', in a gene called RET. This change makes the cancer grow.

What is NSCLC?

NSCLC stands for Non-Small Cell Lung Cancer. It's a common type of lung cancer.

What is EP0031?

EP0031 is a new medicine being tested. It's designed to specifically target the faulty RET gene in cancer cells.

Why is this study important if other RET treatments exist?

This study is particularly important because EP0031 aims to work even if other RET treatments have stopped being effective for the cancer.

Can I still get other cancer treatments if I join?

Generally, while in the study, you would receive the study drug. Your doctor will discuss what other treatments are allowed or not allowed during your participation.

How to find out more

Clinical Trials Team

Enquires@ellipses.life +44 20 3743 0992 Official trial record

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