RecruitingPHASE2INTERVENTIONAL

A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery

This research study is looking at a new treatment called Radspherin for people with advanced ovarian, fallopian tube, or primary peritoneal (lining of the tummy) cancer that has spread to the tummy area. These cancers are called 'epithelial' cancers. The study aims to find out if Radspherin is effective and safe when given as a single injection into the tummy alongside usual chemotherapy (before surgery) and a major operation to remove as much cancer as possible. Participants in this study will have cancer that doctors think can be completely removed during surgery. The study involves two parts, starting with a small group to check safety, followed by a larger, randomised part.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Oncoinvent Solutions AS

Enrolment target

114

Start

15 Jun 2024

Estimated completion

28 Feb 2031

Peritoneal Carcinomatosis Ovarian Cancer

What is this study about?

This study is exploring a new treatment called Radspherin for advanced cancers that start in the ovary, fallopian tube, or the lining of the tummy (peritoneum). Specifically, it's for certain types of these cancers that are classed as high-grade serous or endometrioid epithelial, and have spread within the tummy (peritoneal metastasis). Doctors believe that for people joining this study, most, if not all, of the cancer can be removed through surgery.

The main goal of this study is to see how well Radspherin works and whether it’s safe. It's being tested in combination with the usual treatment approach, which involves chemotherapy first (called 'neoadjuvant chemotherapy') to shrink the tumours, followed by a significant operation (called 'interval debulking surgery') to remove as much cancer as possible. The study is particularly for people whose cancer cells show a specific feature called 'homologous recombination proficient' (HR proficient).

By taking part, you would be helping researchers understand if Radspherin can improve outcomes for this particular group of patients. It's a 'Phase 2' study, meaning it's still an early stage of testing new treatments, focusing on finding the right dose and further assessing its effectiveness and safety before potentially moving to larger studies.

Key takeaways

This study is for women with advanced ovarian, fallopian tube, or peritoneal cancer.
It tests a new treatment called Radspherin alongside standard chemotherapy and surgery.
The main goal is to see if Radspherin is safe and effective.
You need to have a specific type of cancer and be fit enough for major surgery.
Participation involves regular appointments and health checks.
You can stop participating at any time.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer. This includes cases where the cancer has spread within the tummy area. Your doctors must believe that it's possible to remove all visible cancer during surgery.

Before joining, it's important that you have recovered well from any previous cancer treatments, with side effects mostly gone or mild. Your cancer must also have a specific genetic feature called 'HR proficient', and your body systems (kidneys, liver, blood) need to be working well enough to safely participate. Your general fitness level, as assessed by your doctor, should be suitable for major surgery and further treatment.

You will also need to be willing to follow the study's rules and attend all appointments. If you are able to become pregnant, you'll need to use effective contraception during the study and for 9 months after receiving Radspherin, unless you have had your womb or ovaries removed.

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 a woman aged 18 or older?
Do you have advanced ovarian, fallopian tube, or primary peritoneal cancer?
Has your doctor confirmed that your cancer might be fully removable by surgery?
Have you recovered well from previous cancer treatments?
Are your kidney, liver, and blood test results within healthy ranges for surgery?
Are you considered fit enough for major surgery by your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will go through a series of steps. Initially, you'll have some tests to make sure you're suitable for the study. If you are, you will receive chemotherapy before your surgery as planned by your doctors. At some point, you will receive a single injection of Radspherin directly into your tummy area. This is done during a planned procedure.

After the injection, you will have your main cancer surgery to remove as much of the cancer as possible. Throughout the study, you will have regular visits with the study team. These visits will involve blood tests, scans, and physical examinations to check how you're responding to treatment and to monitor for any side effects. The study also involves follow-up appointments after your treatment has finished to see how you are doing in the long term. The total duration of your participation will be explained to you by the study team, and it involves regular check-ups for some time.

Potential risks and benefits

Participating in research studies like this can offer potential benefits, such as access to a new treatment a little earlier than usual which might help control your cancer. However, there's no guarantee that Radspherin will work for you, and it's possible you might not benefit. As with all medical treatments, there are potential risks and side effects associated with Radspherin and the study procedures. The research team will explain these in detail so you can make an informed decision. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (10)

Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Verified postcode
Roma, Italy· Recruiting
The Norwegian Radiumhospital
Verified postcode
Oslo, Norway· Recruiting
Hospital Universitari de Bellvitge
Verified postcode
Barcelona, Spain· Recruiting
Clinica Universidad de Navarra
Verified postcode
Madrid, Spain· Recruiting
Clinica Universidad de Navarra
Verified postcode
Pamplona, Spain· Recruiting
Hospital Universitari i Politècnic La Fe
Verified postcode
Valencia, Spain· Recruiting
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting
University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is Radspherin?

Radspherin is a new treatment being tested in this study to see if it can help treat certain advanced cancers.

What does 'HR proficient' mean?

HR proficient refers to a specific genetic feature of your cancer cells that doctors look for to see if this treatment might be suitable for you.

What is neoadjuvant chemotherapy and interval debulking surgery?

Neoadjuvant chemotherapy is given before surgery to shrink tumours, and interval debulking surgery is an operation to remove as much cancer as possible.

Will I definitely get Radspherin if I join?

The study has two parts; in the main part, you might be randomly chosen to receive Radspherin, or you might be in a group that only receives the standard treatment.

How long will I be in the study?

Your participation will involve treatment and regular check-ups, and the full duration will be explained by the study team before you decide to join.

How to find out more

Anne-Kirsti Aksnes, PhD

aksnes@oncoinvent.com 004722183305 Official trial record

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