Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

This research study is looking into a new treatment called brenetafusp (sometimes called IMC-F106C) for people with specific types of advanced solid cancers. These are cancers that require a special marker called PRAME to be present, and patients also need a particular inherited tissue type called HLA-A2. The study aims to find out the safest and most effective dose of brenetafusp. It will be given either on its own or in combination with other existing cancer treatments, such as chemotherapy, immunotherapy, or other targeted drugs. By doing this, researchers hope to understand if brenetafusp can help control the cancer and improve patient well-being, especially for those whose previous treatments haven't worked.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Immunocore Ltd

Enrolment target

410

Start

25 Feb 2020

Estimated completion

01 Dec 2027

Select Advanced Solid Tumors

What is this study about?

This research study is about a new potential cancer medicine called brenetafusp (also known as IMC-F106C). It's designed to help your body's own immune system fight cancer. Brenetafusp works by targeting a specific protein called PRAME, which is found on the surface of some cancer cells. For this treatment to work, your cancer needs to have this PRAME protein, and you also need a particular gene marker called HLA-A2 in your body.

The study is split into two main parts. The first part aims to find the right and safest dose of brenetafusp. Researchers will test it alone and in combination with other well-known cancer treatments, like chemotherapy, other immune-boosting drugs, or targeted therapies. This is to see how well these combinations are tolerated and what dose is best to move forward with. In the second part, once the best dose is found, the study will focus on how well brenetafusp works to treat specific advanced solid cancers.

This is a "first-in-human" trial, meaning it's one of the first times this drug is being tested in people. The goal is to see if brenetafusp can be a useful new option for adults with advanced solid cancers that have either returned, not responded to standard treatments, or if the patient can't tolerate those standard treatments. The study aims to make sure the treatment is safe and to see how effective it is in shrinking or controlling the cancer.

Key takeaways

This study is testing a new cancer medicine, brenetafusp, for specific advanced solid cancers.
Brenetafusp works with your immune system to target cancer cells with the PRAME protein.
You need to have a specific genetic marker (HLA-A2) for this treatment.
It aims to find the safest dose and see how well it works, both alone and with other treatments.
Participation involves regular check-ups, and side effects are closely monitored.
This is an opportunity for those whose current treatments are no longer effective or tolerated.

Who may be eligible?

To join this study, you need to be an adult with a type of advanced solid cancer that has either returned, not fully responded to previous treatments, or if you couldn't tolerate those treatments. Your cancer must have a specific marker called PRAME, and you must also have a genetic marker called HLA-A*02:01. You should generally be fit and able to carry out your daily activities.

There are several reasons why you might not be able to join. For example, if you have cancer that has spread to your brain and is causing symptoms, or if you've recently had problems with your bowel. Serious or ongoing infections like Hepatitis B, Hepatitis C, or HIV would also mean you can't take part. If you have any serious heart, lung, or immune system conditions, or if you're currently pregnant or breastfeeding, this study would not be suitable 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 (18 or older)?
Do you have an advanced solid cancer that has progressed or not responded to other treatments?
Do you know if your cancer has the PRAME marker?
Do you know if you have the HLA-A*02:01 genetic marker?
Are you generally feeling well and able to manage daily activities?
Are you able and willing to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive brenetafusp, potentially alongside other cancer medicines. You'll have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. Depending on the phase of the study and the combination of treatments being used, these visits might be weekly or every few weeks. Doctors will closely watch for any side effects. The total length of your participation will depend on how you respond to the treatment and the study's design for your specific situation. You might also need to use effective contraception if you are able to become pregnant.

Potential risks and benefits

Participating in a clinical trial offers the chance to try a new treatment that might help your cancer when standard options haven't worked or aren't suitable. While there's no guarantee the treatment will work for you, your health will be closely monitored, and you'll receive dedicated medical care. However, new drugs can have side effects that aren't fully known yet, and some could be serious. There's also the chance the treatment might not help your cancer. Remember, joining is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

Locations (76)

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

University of California - San Diego
Verified postcode
La Jolla, United States
Angeles Clinic and Research Institute
Verified postcode
Los Angeles, United States
University of California Davis Comprehensive Center
Verified postcode
Sacramento, United States
University of Colorado
Verified postcode
Aurora, United States
Georgetown University Medical Center
Verified postcode
Washington D.C., United States
Houston Lee Moffitt Cancer Center & Research Institute
Verified postcode
Tampa, United States
The University of Chicago Medical Center
Verified postcode
Chicago, United States
University of Iowa
Verified postcode
Iowa City, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
John Theurer Cancer Center at Hackensack University Medical Center
Verified postcode
Hackensack, United States
Columbia University Medical Center
Verified postcode
New York, United States
Memorial Sloan Kettering
Verified postcode
New York, United States

Common questions

What is PRAME?

PRAME is a specific protein found on some cancer cells that this new medicine is designed to target.

What does HLA-A2 mean?

HLA-A2 is a specific genetic marker that your body needs to have for this immune treatment to work effectively.

Will I get brenetafusp alone or with other drugs?

That depends on which part of the study you join. It might be given by itself or combined with other common cancer treatments.

What if my cancer has spread to my brain?

If your cancer has spread to your brain and is causing symptoms, this study may not be suitable for you.

How long will I be in the study?

The length of time you're in the study will vary, depending on how you respond to the treatment and the specific study plan.