RecruitingPHASE1INTERVENTIONAL

A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha

This research study is looking at a new medicine called MOv18 IgE for women aged 18 or over who have advanced ovarian, endometrial, or triple-negative breast cancer. Participants will have cancer that has a specific marker, Folate Receptor Alpha, which the new medicine targets. The study is split into two parts: first, a small group of patients will help find the safest and most effective dose of MOv18 IgE. Then, a larger group will receive this dose to check its safety further and see how well it fights the cancer. Patients will receive the medicine for up to 21 days each cycle and will be carefully monitored throughout the study.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Epsilogen Ltd

Enrolment target

Start

03 Sep 2024

Estimated completion

01 Mar 2027

Advanced Ovarian Cancer Platinum-resistant Ovarian Cancer Triple Negative Breast Cancer (TNBC)Triple -Negative Breast Cancer Endometrial Cancer Advanced Endometrial Cancer

What is this study about?

This study is an early-stage clinical trial (Phase 1) that is testing a new treatment called MOv18 IgE. It's designed for women who have advanced ovarian, endometrial, or triple-negative breast cancer that has continued to grow even after previous standard treatments. The main goal is to see if MOv18 IgE is safe and how well it helps control the cancer. The study is particularly looking at cancers that have a specific protein on their surface called Folate Receptor Alpha (FRa).

MOv18 IgE is a new type of medicine that is an antibody. This antibody is designed to specifically target and attach to cancer cells that have the FRa protein. By attaching to these cells, the medicine aims to help the body's immune system fight the cancer more effectively. The researchers hope that by targeting FRa, this new treatment could offer an option for patients where other treatments may not have worked as well.

The study involves two main parts. In the first part, a small number of patients will receive different doses of MOv18 IgE to find the highest dose that can be given safely without too many side effects. This is called finding the 'maximum tolerated dose'. Once a safe and suitable dose is found, the second part of the study will involve more patients receiving that specific dose. This will help researchers gather more information on the medicine's safety and see how much it helps to shrink or control the cancer.

Key takeaways

This is an early-stage study testing a new medicine for advanced cancers.
It targets cancers with a specific marker called Folate Receptor Alpha (FRa).
The study aims to find a safe dose and check if the medicine helps control cancer.
Participation involves regular hospital visits, infusions, and monitoring.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for women aged 18 or older who have advanced ovarian cancer (including primary peritoneal or fallopian tube cancer), endometrial cancer (not including a type called endometrial sarcoma), or triple-negative breast cancer.

Your cancer must have a specific marker called Folate Receptor Alpha (FRa). This will be checked using a sample of your tumour tissue. If you've had a biopsy recently, they might be able to use that tissue, or you might need a new, low-risk biopsy to check for this marker.

Also, your ovarian cancer must be 'platinum-resistant', meaning it has not responded well to certain chemotherapy drugs. Your cancer should have progressed after no more than four different types of standard treatments.

Quick self-check

Are you a woman aged 18 or older?
Do you have advanced ovarian, endometrial, or triple-negative breast cancer?
Has your ovarian cancer been identified as 'platinum-resistant'?
Does your cancer tissue show the Folate Receptor Alpha (FRa) marker?
Have you had no more than 4 previous lines of standard treatment for your cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, your journey will involve a few steps. First, there will be a 'screening' period for up to 28 days before you start treatment. During this time, you'll have various tests to make sure the study is right for you, including blood tests, physical exams, and possibly a new biopsy if needed to check for the FRa marker.

Once you begin treatment, you'll receive the MOv18 IgE medicine through an infusion (like a drip) three times during a 21-day cycle (on Days 1, 8, and 15). You'll continue these cycles for as long as the treatment is helping you and you're not experiencing serious side effects that can't be managed. The starting dose for the medicine is 3mg, but in the first part of the study, this dose might be adjusted for other patients to find the safest level.

Throughout the study, you'll have regular appointments for safety checks, blood tests, and scans to see how your tumour is responding. After you stop treatment, you'll be followed up for about 9 months (270 days) to monitor your overall health and longer-term effects of the medicine.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits. You would be among the first to try a new medicine that could help control your cancer, especially if other treatments haven't worked well. However, it's important to remember that this is an early-stage study, so the benefits are not guaranteed. There might also be risks, as new medicines can have side effects that are not fully known yet. These could range from mild to more serious reactions. The study team will carefully monitor you for any side effects and manage them as best they can. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (7)

Bristol Haematology and Oncology Centre
Bristol, United Kingdom· Recruiting
Edinburgh Cancer Research Centre
Edinburgh, United Kingdom· Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom· Recruiting
Cambridge University - Addenbrooke's Hospital
London, United Kingdom· Recruiting
University College London Hospital
London, United Kingdom· Recruiting
Guy's Hospital
London, United Kingdom· Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom· Recruiting

Common questions

What does 'Platinum-resistant ovarian cancer' mean?

This means your ovarian cancer has either not responded or has come back relatively quickly after treatment with certain chemotherapy drugs called platinum-based therapies.

What is Folate Receptor Alpha (FRa)?

FRa is a protein found on the surface of some cancer cells. This study's new medicine is designed to specifically target cancer cells that have this protein.

What is triple-negative breast cancer?

Triple-negative breast cancer is a type of breast cancer that doesn't have the three most common 'receptors' - oestrogen receptor, progesterone receptor, and HER2 receptor. This means many standard hormone and HER2-targeted therapies are not effective.

Will I know if the medicine is working?

The study team will regularly perform scans and other tests to see how your cancer is responding to the treatment. They will share this information with you.

What does 'Phase Ib' mean for a clinical trial?

Phase Ib means this is an early study primarily focused on finding a safe dose and seeing how well a new medicine is tolerated. It also starts to look at how effective it might be.

How to find out more

Epsilogen Clinical Trials

info@epsilogen.com +44 (0) 203 657 7612 Official trial record

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