RecruitingPHASE2INTERVENTIONAL

A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations

This research study, called FORE8394, is investigating a new drug called plixorafenib. It's for people aged 10 and over who have certain cancers where there's a genetic change in something called the BRAF gene. This includes various solid tumours and brain tumours that have either spread, come back, or grown. The main goals are to find out how effective plixorafenib is at treating these cancers and to understand any side effects it might have. This is a Phase 2 study, which means it builds on earlier research to gather more information on effectiveness and safety in a larger group of people.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Fore Biotherapeutics

Enrolment target

254

Start

21 Feb 2023

Estimated completion

28 Dec 2026

Cancer Harboring BRAF Alterations HGG LGG Solid Tumors

What is this study about?

This study is looking into a new medicine called plixorafenib for people who have certain types of cancer. The cancers included in this study all share a common feature: they have a specific change in a gene called BRAF. Genes are like instruction manuals for our bodies, and sometimes changes in these instructions can cause cancer to grow. This study is trying to find out if blocking this specific BRAF change with plixorafenib can help treat the cancer.

Researchers are interested in different kinds of solid tumours (cancers that form a lump) and brain tumours that might have this BRAF change. This includes cancers that have grown, come back after treatment, or spread to other parts of the body. The study wants to see how well plixorafenib works to stop or slow down the cancer, and also to thoroughly check for any side effects it might cause.

This is a Phase 2 study. In cancer research, new treatments go through different 'phases' of testing. Phase 1 trials usually test a new medicine in a small group of people to find a safe dose. Phase 2 trials, like this one, involve more people and aim to get a better idea of how well the medicine works and to continue checking its safety. The information gathered from this study will help decide if plixorafenib should be studied further in a larger Phase 3 trial.

Key takeaways

This study is testing a new drug, plixorafenib, for specific cancers with a BRAF gene change.
It's a Phase 2 study, focusing on how well the drug works and its safety.
Participants must be at least 10 years old and have certain types of cancer with a BRAF alteration.
You would usually have already tried standard treatments or they aren't suitable for you.
Participation involves taking the drug and regular check-ups including blood tests and scans.
You can stop participating in the study at any time.

Who may be eligible?

This study is for people who are at least 10 years old and weigh 30 kilograms (about 4 stone 10 pounds) or more. You would need to have been diagnosed with a solid tumour or a brain tumour that has a specific change in its BRAF gene. This BRAF gene change needs to be confirmed by special tests on your tumour or blood.

Generally, you would have already received the standard treatments for your cancer, or these treatments might not be suitable for you, or you might not have been able to tolerate them. Any side effects from your previous treatments would also need to have settled down to a mild level or completely disappeared. The team would also need to be able to get a sample of your tumour from the past for additional testing.

More specifically, for those with brain tumours, the study includes certain types of brain tumours in adults (18 and over) that are unresectable (can't be removed by surgery), or have grown or spread. For younger people (10-17 years old), it includes specific types of more aggressive brain tumours, even if you had a less aggressive one previously. These brain tumours would also need to have been treated with radiotherapy or chemotherapy before, unless these treatments are not considered standard for your particular type of glioma.

Quick self-check

Are you at least 10 years old and weigh 30kg or more?
Do you have a cancer (solid tumour or brain tumour) that has a specific BRAF gene change?
Have you already used standard treatments for your cancer, or are they not suitable for you?
Have any side effects from your previous treatments mostly gone away?
Would you be willing to provide a past tumour sample if needed?

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

What does participation involve?

The study involves taking the medication plixorafenib. You will have regular visits to the clinic for check-ups, which will include examinations, blood tests, and scans to see how the treatment is affecting your cancer. The research team will monitor you closely for any side effects, and you'll need to report any changes in your health. The total duration of the study and how often you'll need to visit will be explained by the study team, but it will involve ongoing assessments as long as you are receiving the treatment and follow-up after the treatment ends.

Potential risks and benefits

Taking part in a clinical trial may offer some potential benefits, such as gaining access to a new treatment that isn't yet widely available and receiving close medical care from a specialist team. However, there are also potential risks. The new medication might cause side effects, some of which could be mild, while others could be more serious or unexpected. The treatment might also not work for everyone. You are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (69)

Precision NextGen Oncology & Research Center
Beverly Hills, United States· Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, United States· Recruiting
University of California Los Angeles Rheumatology
Westwood, Los Angeles, United States· Recruiting
Norwalk Hospital
Norwalk, United States· Recruiting
University of Miami Hospital and Clinics
Miami, United States· Recruiting
The John Hopkins Hospital
Baltimore, United States· Recruiting
Maryland Oncology Hematology- Columbia
Rockville, United States· Recruiting
Tufts Medical Center
Boston, United States· Recruiting
Massachusetts General Hospital
Boston, United States· Recruiting
Dana-Farber Cancer Institute
Boston, United States· Not yet recruiting
St. Luke's Hospital
Duluth, United States· Recruiting
Mosaic Life Care at Saint Joseph - Medical Center
Saint Joseph, United States· Recruiting

+57 more sites — see the official record for the full list.

Common questions

What is the BRAF gene?

The BRAF gene is a part of your body's instruction manual (DNA) that helps control cell growth. Sometimes, a change in this gene can make cancer cells grow out of control. This study is for cancers with a specific change in the BRAF gene.

What is plixorafenib?

Plixorafenib is the new medication being tested in this study. It's designed to specifically target and block the effects of the changed BRAF gene, which researchers hope will help stop or slow down cancer growth.

What does 'Phase 2 study' mean?

A Phase 2 study means the researchers are looking at how effective the new medication is and continuing to check its safety in a larger group of people, after earlier tests suggested it might be helpful.

Will I get the new drug?

If you are eligible and choose to take part in this study, you will receive the study medication, plixorafenib. There is no placebo or 'dummy' drug used in this trial.

What if I get side effects?

The study team will closely monitor you for any side effects. You should tell them immediately about any new or worsening symptoms you experience. They will provide care and support to manage any side effects.

How to find out more

Jessica Rine

jessica.rine@fore.bio 610-442-4517 Official trial record

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