A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
This research is investigating a new treatment, 177Lu-FAP-2286, for people with advanced solid cancers. The treatment specifically targets a protein called FAP, which is often found in large amounts on cells linked to cancer, and sometimes on cancer cells themselves. Phase 1 of the study focuses on finding a safe dose of 177Lu-FAP-2286. Phase 2 will then look at how safe and effective this treatment is, both on its own and when combined with standard chemotherapy, for specific cancers like pancreatic, lung, and breast cancer. Only people whose cancer shows the FAP protein will be considered for this treatment.
At a glance
What is this study about?
This study is a clinical trial exploring a new approach to treating advanced solid cancers. It's focused on a substance called 177Lu-FAP-2286. What makes this treatment interesting is that it's designed to specifically target a protein known as FAP (Fibroblast Activation Protein). This FAP protein is often found in high amounts on helper cells around most common cancers. In some less common cancers, like sarcoma and mesothelioma, it can even be on the cancer cells themselves. Because FAP is not usually found in healthy body tissues, scientists believe it could be a good target for cancer treatments to reduce harm to healthy cells.
The study has two main parts, called phases. Phase 1 is all about safety and finding the right dose. The research team will give different doses of 177Lu-FAP-2286 to participants with various FAP-positive solid cancers to see what dose is both safe and can be recommended for future studies. Phase 2 then expands on this by testing the treatment in specific advanced cancers: pancreatic, non-small cell lung, and breast cancer. In this phase, they'll check how safe and effective 177Lu-FAP-2286 is, both on its own and in combination with chemotherapy for certain types of pancreatic and lung cancers.
Before anyone can receive the 177Lu-FAP-2286 treatment, they will have a special scan using a substance called 68Ga-FAP-2286. This scan helps doctors see if the FAP protein is present in their cancer. Only those whose scans confirm the presence of FAP in their tumours will be eligible to continue with the trial treatment. This careful selection ensures the treatment is given to people who are most likely to benefit.
Key takeaways
- This is a study for advanced solid tumours targeting the FAP protein.
- It aims to find a safe dose and see how well the new drug 177Lu-FAP-2286 works.
- A special scan will confirm if your cancer has the FAP protein before treatment.
- Treatment is given by IV usually every 4 or 6 weeks, with regular monitoring.
- Some participants may receive the new drug with chemotherapy.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you would need to meet certain requirements. You must be at least 18 years old and capable of giving your informed consent. Doctors will check your overall health, including how well your kidneys, liver, and bone marrow are working through blood tests. Your general fitness level, as assessed by a doctor, should also be good, and your life expectancy needs to be at least six months.
Importantly, your cancer must be a 'solid tumour' and show signs of the FAP protein on a special scan. You would also need to have measurable cancer that doctors can track. For some parts of the study, you might also be asked to provide a sample of your tumour tissue if available.
While this study is for advanced solid tumours, it's very specific about which ones and in what stage. If you're interested, your doctor can review the detailed criteria to see if this trial might be suitable for your particular situation.
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 at least 18 years old?
- Do you have a solid tumour that is advanced?
- Are you able to have regular hospital visits and scans?
- Are your kidney, liver, and blood counts generally good?
- Is your general fitness level considered good by your doctor?
What does participation involve?
If you decide to take part, the first step is a 'screening' period. This involves several checks, including scans like CT or MRI, to assess your cancer. You'll also have blood tests to check your organ health and tissue samples might be collected if available. Everyone will have a special scan using 68Ga-FAP-2286 to see if your cancer has the FAP protein. Only if this scan is positive will you be able to continue with the trial treatment.
Once enrolled, the main treatment involves receiving the study drug, 177Lu-FAP-2286, through a drip (intravenous, or IV). In Phase 1, you'd receive a single dose every 6 weeks, up to a maximum of 6 doses. In Phase 2, the treatment is given every 4 weeks. Throughout this time, you'll have regular hospital visits to monitor your safety and check how your cancer is responding with scans every 6 weeks. Some participants in Phase 2 might also receive standard chemotherapy alongside the study drug.
Treatment will continue as long as it's safe for you, your cancer isn't getting worse, and you're willing to continue. You can withdraw from the study at any time.
Potential risks and benefits
Locations (40)
- UAB Comprehensive Cancer CenterVerified postcodeBirmingham, United States· Recruiting
- City of HopeVerified postcodeDuarte, United States· Recruiting
- Hoag Hospital IrvineVerified postcodeIrvine, United States· Recruiting
- University of California Los Angeles (UCLA)Verified postcodeLos Angeles, United States· Recruiting
- UCSF Medical CenterVerified postcodeSan Francisco, United States· Recruiting
- Mayo ClinicVerified postcodeJacksonville, United States· Recruiting
- University of Miami Hospital and ClinicsVerified postcodeMiami, United States· Recruiting
- University of Chicago Medical CenterVerified postcodeChicago, United States· Recruiting
- University of Iowa Hospitals and ClinicsVerified postcodeIowa City, United States· Recruiting
- Karmanos Cancer InstituteVerified postcodeDetroit, United States· Recruiting
- Mayo ClinicVerified postcodeRochester, United States· Recruiting
- Saint Louis University HospitalVerified postcodeSt Louis, United States· Recruiting
Common questions
What is a 'solid tumour'?
A solid tumour is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas. Most cancers, like breast, lung, or bowel cancer, form solid tumours.
What is the FAP protein?
FAP (Fibroblast Activation Protein) is a protein found on the surface of certain cells. In many cancers, it's highly expressed on 'helper cells' around the tumour, and sometimes on the cancer cells themselves, making it a target for treatments.
What is 177Lu-FAP-2286?
It's an experimental treatment aiming to target and deliver treatment specifically to cancer or surrounding cells that have the FAP protein, potentially reducing harm to healthy tissues.
Will I have chemotherapy in this study?
Not everyone. In Phase 2, some participants with specific cancers (pancreatic or lung cancer) might receive 177Lu-FAP-2286 alongside standard chemotherapy, while others will receive the new treatment by itself.
How long will I be in the study?
The treatment period varies, but you'll receive doses every 4 or 6 weeks. You will continue as long as the treatment is helping, safe, and you wish to participate, or until a maximum number of doses is reached.
How to find out more
Novartis Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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