FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
This research study, called FORAGER-1, is investigating a new medicine named LOXO-435. It's designed for people with certain cancers, particularly those affecting the bladder and urinary system, where a specific gene called FGFR3 has changed. The main goals are to understand how safe LOXO-435 is, what side effects it might cause, and how well it works. Researchers are studying it by itself and in combination with other common cancer treatments like Pembrolizumab and enfortumab vedotin. The study will last around two and a half years, potentially longer if the medicine is helping. This is a very early-stage study (Phase 1) focused on finding the right dose and checking for safety.
At a glance
What is this study about?
This study, called FORAGER-1, is an important step in understanding a new medicine called LOXO-435. It's being tested in people who have certain types of cancer, especially bladder and urinary tract cancers, where a specific genetic change (called an FGFR3 alteration) has been found in their cancer cells. This genetic change can sometimes make cancers grow, so targeting it might be a way to help reduce or control the disease.
The main purpose is to carefully check if LOXO-435 is safe to use and what side effects it might cause. Researchers also want to see how well it works, both on its own and when given together with other widely used cancer medicines like Pembrolizumab or enfortumab vedotin. This study is in its very early stages (Phase 1), which means it's focused on finding the best and safest dose of LOXO-435 before it's studied in larger groups of people.
By taking part, you would be helping doctors learn more about how to treat cancers with this specific genetic change. The information gathered from this study could lead to new treatment options in the future. It's a way for patients to potentially access a new medicine that isn't yet widely available, while also contributing to medical knowledge.
Key takeaways
- This study is testing a new medicine (LOXO-435) for cancers with a specific gene change (FGFR3).
- It's mainly for bladder and urinary system cancers, and other solid tumours, that have this change.
- The study aims to understand the medicine's safety, side effects, and how well it works.
- Participation could last up to 2.5 years, or longer if the treatment is beneficial.
- This is an early-stage (Phase 1) study focused on finding the right dose and checking for safety.
Who may be eligible?
To be considered for this study, you would generally need to have a solid tumour cancer where a specific change in the FGFR3 gene has been found. This change needs to be identified from a test on your tumour tissue or blood. The study is particularly looking for people with advanced or spreading bladder cancer, but also other solid tumours with this FGFR3 change.
You would also need to be well enough to take part in a study like this. Doctors use a scale called ECOG to assess this; generally, you'd need to be able to carry out your daily activities with little to no difficulty. Your doctors will also need to be able to measure your cancer, meaning they can see its size and track any changes.
Depending on the specific part of the study, you might have already received different cancer treatments, or for some parts, you might not have had any prior treatment for your advanced disease. Your medical team will review all your detailed medical information to see if this study could be a good fit 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.
- Do I have a solid tumour cancer?
- Has my cancer been tested for changes in the FGFR3 gene?
- Is my cancer advanced or has it spread?
- Am I generally well enough to participate in a study?
- Do my doctors believe my cancer can be measured or tracked?
- Have I had previous cancer treatments (if applicable to the study part)?
What does participation involve?
If you join this study, your involvement could last up to two and a half years, and potentially even longer if the treatment is continuing to help you. The study involves taking the medicine LOXO-435, either by itself or combined with other existing cancer medicines like Pembrolizumab or enfortumab vedotin. You will have regular appointments where doctors will carefully monitor your health. These visits will involve various tests to check how the medicine is affecting you, how well it's working, and to look for any side effects. This includes blood tests, scans, and other assessments. You'll be closely observed throughout, and the study team will provide all the necessary support and information.
Potential risks and benefits
Locations (82)
- University of Arizona - Cancer CenterVerified postcodeTucson, United States· Recruiting
- City of HopeVerified postcodeDuarte, United States· Recruiting
- University of California, Los Angeles (UCLA) - Division of Hematology-OncologyVerified postcodeLos Angeles, United States· Recruiting
- University of California - IrvineVerified postcodeOrange, United States· Recruiting
- University of California (UC) Davis Comprehensive Cancer CenterVerified postcodeSacramento, United States· Recruiting
- Stanford Medicine Cancer CenterVerified postcodeStanford, United States· Recruiting
- Advent HealthVerified postcodeOrlando, United States· Recruiting
- Emory University HospitalVerified postcodeAtlanta, United States· Recruiting
- The University of Chicago Medical Center (UCMC)Verified postcodeChicago, United States· Recruiting
- Indiana University (IU) Melvin and Bren Simon Cancer CenterVerified postcodeIndianapolis, United States· Recruiting
- Mary Bird Perkins Cancer CenterVerified postcodeBaton Rouge, United States· Recruiting
- Ochsner Clinic FoundationVerified postcodeNew Orleans, United States· Recruiting
Common questions
What is FGFR3, and why is it important?
FGFR3 is a gene. When it changes in certain ways, it can make cancer cells grow. This study is testing a medicine designed to target these specific changes.
What type of cancer is this study for?
It's mainly for bladder and urinary tract cancers that have a specific change in the FGFR3 gene, but also other solid tumours that carry this genetic change.
How long will I be in the study if I participate?
Your participation could last up to two and a half years, and possibly longer if the treatment is helping to control your cancer.
What medicines will I be taking?
You would be taking a new medicine called LOXO-435, either on its own or alongside other standard cancer treatments like Pembrolizumab or enfortumab vedotin.
What does Phase 1 mean for a clinical trial?
Phase 1 is the earliest stage of human trials. It mainly focuses on checking if a new medicine is safe, finding the right dose, and looking for any side effects.
How to find out more
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.