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Study of TYRA-300-B01 tablets in patients with low grade, intermediate risk non-muscle invasive bladder cancer who have FGFR3 gene changes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with non-muscle invasive bladder cancer, specifically a type that has changes in a gene called FGFR3. The cancer in this study is classified as low grade and intermediate risk, which means it has certain characteristics such as returning within a year or appearing in multiple locations in the bladder. The study will test a new medication called TYRA-300, which comes in tablet form and is taken by mouth.

The purpose of this research is to evaluate how well TYRA-300 works and how safe it is for treating this specific type of bladder cancer. The study will last up to 24 months, during which participants will receive the study medication. Before starting the treatment, doctors will examine the bladder and identify specific areas of cancer to monitor throughout the study.

During the study, doctors will regularly check how the cancer responds to the treatment, particularly after the first 3 months. They will also monitor how long any positive responses to the treatment last and track any changes in the cancer over time. Throughout the study, participants will have regular check-ups to monitor their health and any effects of the medication.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your eligibility for the study will be confirmed based on specific criteria, including being 18 years or older and having low grade bladder cancer that has not invaded the muscle.
A genetic test will be performed to confirm the presence of specific FGFR3 alterations in your cancer.
Various health assessments will be conducted to ensure adequate bone marrow, liver, and kidney function.
Step 2
Tumor mapping procedure
A detailed mapping of your bladder will be performed to identify and measure tumor locations.
The tumor(s) must be between 3mm and 12mm in size to serve as marker lesions for monitoring treatment response.
Step 3
Treatment initiation
The study medication TYRA-300 will be provided in tablet form for oral use.
You will receive specific instructions about the dosing schedule and how to take the medication.
Step 4
Follow-up evaluations
Your response to treatment will be evaluated after 3 months to assess if there is a complete response (disappearance of tumor).
Regular assessments will continue for up to 24 months to monitor for any cancer recurrence.
Blood tests will be performed to measure how the medication is processed by your body.
Any side effects or changes in your health will be monitored throughout the study period.
Step 5
Study completion
The study is expected to continue until August 2028.
Your participation may end earlier depending on your response to treatment or other factors determined by the study protocol.

Who can join the trial?

12 criteria

Must be 18 years or older
Must have been diagnosed with low grade bladder cancer that has not invaded the muscle wall, confirmed by tissue examination within 6 weeks before study start
Must have visible tumor(s) between 3 mm and 12 mm in size that will serve as marker lesions
Must have intermediate risk bladder cancer with at least one of these features: - Cancer that has returned within 1 year - Single tumor larger than 3cm - Multiple tumors - Cancer that has grown into the tissue beneath the bladder lining
Must have a specific genetic change (FGFR3 mutation or fusion) in the tumor
Must have had bladder mapping (examination of entire bladder) within 6 weeks before study start
Must not have cancer in the upper urinary tract or prostate channel (confirmed by imaging) within 6 months before study start
Must not have received BCG treatment (a type of bladder immunotherapy) within 1 year
Must not have received medication directly into the bladder within 8 weeks before study start
Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities)
Must have cancer cells that are purely of bladder origin (or at least 80% if mixed type)
Must have adequate function of bone marrow, liver, and kidneys as shown by blood tests

Who cannot join the trial?

13 criteria

Known allergy or sensitivity to any component of TYRA-300 (the study medication)
History of other cancers within the past 5 years (except successfully treated non-melanoma skin cancer)
Pregnant or breastfeeding women
Serious heart conditions, including uncontrolled high blood pressure or recent heart attack (within 6 months)
Severe liver problems or abnormal liver function tests
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Major surgery within 4 weeks before starting the study
Participation in other clinical trials within 30 days before this study
Mental conditions that could interfere with following study procedures
Substance abuse within the past year
Any condition that the study doctor believes would make participation unsafe
Unable to swallow oral medications
History of bleeding problems or currently taking blood thinners

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero Universitaria Pisana
Verified
Pisa, Italy
Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

Trial locations

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Investigated drugs

TYRA-300 is an investigational medication being studied for treating bladder cancer. It specifically targets cancers that have changes (alterations) in a protein called FGFR3. This medication is designed to help patients with a specific type of bladder cancer that has not invaded the muscle layer of the bladder wall, known as non-muscle invasive bladder cancer (NMIBC). The medication works by blocking certain signals that can cause cancer cells to grow and spread.

Tyra-300-B01

What is already known about the treatment

TYRA-300 - An investigational medication currently being studied in Phase 2 clinical trials for the treatment of non-muscle invasive bladder cancer (NMIBC), specifically targeting patients with FGFR3 alterations. The drug is being evaluated in patients with low-grade, intermediate-risk bladder cancer that hasn't spread into the muscle layer of the bladder wall. While the exact mechanism of action involves targeting the FGFR3 (Fibroblast Growth Factor Receptor 3) pathway, which is commonly altered in bladder cancer, the complete safety and efficacy profile is still being established through ongoing clinical research. The medication represents a targeted therapeutic approach in oncology, though as an investigational drug, it is not yet approved for general medical use and is only available through clinical trials.

Investigated diseases

Non-muscle invasive bladder cancer (NMIBC) - A type of bladder cancer where the tumor cells are found only in the inner lining of the bladder without penetrating into the muscle layer. The cancer begins in the cells that line the bladder's inner surface and grows inward toward the bladder's hollow center. This condition primarily affects the urothelium, which is the innermost lining of the bladder. NMIBC may appear as small growths on the bladder's surface that can multiply over time. The disease can recur in different areas of the bladder's lining after initial occurrence.