RecruitingPHASE1INTERVENTIONAL

Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations

This research study is looking at a new medicine called TYRA-430 for people with advanced liver cancer (hepatocellular carcinoma) or other advanced solid tumours. These cancers must have certain changes in their genes, specifically in pathways called FGF/FGFR. TYRA-430 is designed to block these specific pathways. The main goals of this study are to find out if TYRA-430 is safe and how much of it the body can handle. Researchers will also check how the medicine moves through the body and if it has any early signs of shrinking tumours. This is a Phase 1 study, meaning it's one of the first times this medicine is being tested in humans.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Tyra Biosciences, Inc

Enrolment target

100

Start

24 Apr 2025

Estimated completion

01 Sep 2028

Metastatic Hepatocellular Carcinoma Solid Tumors Solid Tumor, Adult FGFR Gene Amplification FGFR Gene Alterations FGFR3 Gene Alteration FGFR3 Gene Mutation Advanced Solid Tumors FGFR4 Gene Mutation FGFR4 Gene Fusions FGF19 Gene Amplification FGF19 Gene Overexpression FGFR3 Gene Fusions Locally Advanced Unresectable Hepatocellular Carcinoma

What is this study about?

This study is testing a new medicine called TYRA-430. It's designed for people who have advanced cancer, specifically a type of liver cancer called hepatocellular carcinoma, or other solid tumours that have spread. The key thing about these cancers is that they must have certain changes in their genes, particularly in something called the FGF/FGFR pathway. Think of these pathways as instruction routes within your cells; when they change, cancer can grow more easily. TYRA-430 aims to block these faulty instructions.

The main purpose of this study is to see if TYRA-430 is safe for people to take and to figure out the right dose. Researchers will also look at how the medicine works in the body and if it shows any early signs of helping to shrink tumours. This is important research because it could lead to new ways of treating these cancers, especially for people whose current treatments are no longer working.

This is a 'first-in-human' study, which means it's one of the first times this specific medicine has been given to people. It's an important step in developing new treatments. The study is open to people worldwide and will gather information from carefully selected patients to understand TYRA-430 better.

Key takeaways

This study is for advanced liver cancer or other advanced solid tumours.
Your cancer must have specific genetic changes (FGF/FGFR pathways).
It's a Phase 1 study, focused on safety and finding the right dose of a new medicine, TYRA-430.
You would have already received standard treatments for your cancer.
Participation involves taking a new oral medicine, regular clinic visits, and monitoring.

Who may be eligible?

This study is for adults aged 18 or older who are generally well enough to take part and can swallow medicines by mouth. You also need to be able to understand what’s involved and agree to join the study by signing a consent form.

Specifically, if you have advanced liver cancer that can’t be removed or has spread, or another advanced solid tumour, you might be eligible. Your cancer must have specific genetic changes in the FGF/FGFR pathway. You would have already received standard treatments for your cancer, and it's okay if you've already had other similar targeted therapies.

For some parts of the study, if you have liver cancer, it needs to be at a specific stage (BCLC stage B or C) and your liver function needs to be good (Child-Pugh Score class A). The research team will also check if a sample of your tumour tissue from within the last two years is available for them to review.

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 18 years old or older?
Do you have advanced liver cancer or another advanced solid tumour?
Does your cancer have specific FGF/FGFR genetic changes?
Have you already received standard treatment for your cancer?
Are you generally well enough for a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be taking the new medicine, TYRA-430, which comes in a pill form. The study will involve regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and see how the medicine is working. You'll also be asked to provide tumour tissue (from a past biopsy or surgery if available) for analysis.

The total duration of your participation will depend on how you respond to the treatment and your health. You'll be closely monitored throughout the study, and the research team will explain all the assessments and visits in detail before you decide to join.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be that TYRA-430 helps control or shrink your tumour, especially if other treatments haven't worked. However, it's a new medicine, so there's no guarantee it will help you, and you might experience side effects, some of which could be serious. The research team will monitor you closely for any side effects and will explain all known and possible risks before you join. Remember, taking part is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

Locations (16)

USC Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Recruiting
UCSF Medical Center at Mount Zion
Verified postcode
San Francisco, United States· Recruiting
Stanford Cancer Institute
Verified postcode
Stanford, United States· Recruiting
The University of Kansas Medical Center
Verified postcode
Westwood, United States· Recruiting
John Hopkins University
Verified postcode
Baltimore, United States· Recruiting
Mass General Cancer Center
Verified postcode
Boston, United States· Recruiting
Karmanos Cancer Institute
Verified postcode
Detroit, United States· Recruiting
Columbia University Irving Medical Center
Verified postcode
New York, United States· Recruiting
Sarah Cannon Research Institute Oncology Partners
Verified postcode
Nashville, United States· Recruiting
University Health Network Princess Margaret Cancer Center
Verified postcode
Toronto, Canada· Recruiting
Asan Medical Center
Verified postcode
Seoul, South Korea· Recruiting
Samsung Medical Center
Verified postcode
Seoul, South Korea· Recruiting

Common questions

What is TYRA-430?

TYRA-430 is a new experimental medicine being tested in this study. It's designed to target specific genetic changes in cancer cells (FGF/FGFR pathways).

What does 'FGF/FGFR pathway aberrations' mean?

This refers to specific changes or mistakes in the genes that control how cancer cells grow. TYRA-430 is designed to block these faulty signals to stop cancer growth.

Is this medicine available outside the study?

No, TYRA-430 is an experimental medicine and is not currently available outside of clinical trials like this one.

What phase is this study?

This is a Phase 1 study, which means it's one of the first times this new medicine is being given to people. The main focus is on safety and finding the right dose.

Will my regular doctors still be involved?

Yes, your regular medical team will still be involved in your overall care while you participate in the study.

How to find out more

Grace Indyk

tyraclinicaltrials@tyra.bio 858-356-2323 Official trial record

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