A Study of LY4337713 in Participants With FAP-Positive Solid Tumors (FiREBOLT)
The FiREBOLT clinical trial is looking at an experimental medicine called LY4337713. It is designed for adults with advanced solid tumours, including bowel, breast, ovarian, pancreatic, stomach, food pipe (oesophageal), and bile duct cancers. To take part, a person's tumour must have a specific marker called FAP (fibroblast activation protein). Because this is an early-stage 'Phase 1' trial, this is the very first time the medicine is being given to people. Doctors want to find out how safe the drug is, what side effects it might cause, and how it moves through the body. They also want to identify the best and safest dose to use in future studies. Taking part involves attending regular hospital appointments for check-ups, scans, and blood tests to monitor your health closely.
At a glance
What is this study about?
The FiREBOLT trial is exploring a brand-new experimental drug called LY4337713. It is aimed at people with solid tumours that have not responded well to standard treatments. These include cancers of the breast, bowel, stomach, food pipe, pancreas, ovaries, and bile ducts. Researchers want to see if this new treatment can help slow down or stop tumour growth.
The study focuses specifically on tumours that are 'FAP-positive'. FAP stands for fibroblast activation protein. This is a protein found in large amounts in the tissue surrounding certain cancer cells, but rarely in healthy tissue. LY4337713 is designed to find and attach to FAP, potentially delivering treatment straight to where it is needed most while sparing normal cells.
This is a 'Phase 1' clinical trial, which means it is the first time the medicine is tested in human patients. Before this, it was only tested in laboratory settings. The main goal of this early stage is not to prove how well the drug cures cancer, but to check its safety, see what side effects it causes, and find the right dose for future testing.
Trials like this are vital for developing the next generation of cancer treatments. By participating, patients help doctors learn whether targeted drugs like LY4337713 could offer a helpful new path forward for people living with difficult-to-treat cancers.
Key takeaways
- FiREBOLT is testing a new experimental cancer drug called LY4337713.
- This is a Phase 1 trial, testing the medicine in humans for the first time.
- It is for adults with specific solid tumours that test positive for the FAP protein.
- The primary aim is to test safety and determine the best dose.
- Taking part is completely voluntary and requires regular hospital visits.
Who may be eligible?
This trial is open to adults aged 18 and over who have a confirmed solid tumour cancer. This includes cancers of the bowel, breast, ovary, pancreas, stomach, food pipe (oesophagus), or bile duct. A small sample of the tumour (a biopsy) will need to be tested to make sure it contains the FAP protein.
Generally, early-phase trials like this are aimed at people whose cancer has returned or continued to grow despite standard NHS treatments, such as surgery or chemotherapy. Participants must also be well enough to carry out daily tasks independently and have reasonably healthy heart, kidney, and liver function.
You will not be able to take part if you are pregnant or breastfeeding, if you have severe uncontrolled health conditions, or if you have recently had certain other cancer therapies. Your oncology team will look closely at your medical history to see if joining is safe 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.
- I am aged 18 or over.
- I have been diagnosed with an advanced solid tumour (such as breast, bowel, ovarian, pancreatic, or stomach cancer).
- My cancer is willing to be tested, or has already tested positive, for the FAP protein.
- I have already tried standard treatments or have no standard options left.
- I am well enough to attend regular hospital appointments and manage daily self-care.
What does participation involve?
If you decide to join, you will first attend a screening visit. The trial team will run tests, including blood checks, heart tracings (ECGs), and imaging scans (such as CT or MRI), to make sure it is safe for you to take part. You will also have your tumour tissue tested for the FAP protein.
Once accepted, you will receive the study medicine, LY4337713, at a specialist hospital clinic. Because this is a first-in-human trial, you will be watched very closely by doctors and nurses. You will need to visit the hospital frequently, especially in the first few weeks, for doses, blood samples, and safety checks.
Scans will be repeated every few weeks or months to see how your tumour is responding. You will continue on the study as long as the treatment is safe for you and your cancer does not worsen. The total time on the study varies from a few months to over a year, followed by regular check-ups to track your long-term health.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedNetherlands
Common questions
What does a 'first-in-human' trial mean?
It means this is the very first time this specific medicine is being given to people. The main purpose is to find a safe dose and look out for side effects.
What is FAP?
FAP stands for fibroblast activation protein. It is a protein found on the surface of cells in certain tumours. The study drug is designed to seek out this protein.
Will I have to pay for the study treatment?
No. The trial medicine and trial-related tests are provided free of charge, and some travel costs may be covered.
Can I leave the trial if I change my mind?
Yes. You can leave the study at any point, for any reason, and your regular NHS cancer team will continue to care for you.
How is the study drug given?
The medicine is administered under careful supervision in a hospital setting, usually through a drip into a vein (intravenously) or as an injection.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.