Not recruiting

Study of TYRA-300 for Patients with Advanced Bladder Cancer and Other Solid Tumors with FGFR3 Gene Changes

Verified siteInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying a new treatment for advanced urothelial carcinoma and other types of solid tumors that have specific changes in a gene called FGFR3. The treatment being tested is a medication known as TYRA-300, which is taken by mouth in the form of capsules or tablets. The purpose of the study is to find the best dose of TYRA-300 and to see how well it works in treating these cancers.

The study is divided into two phases. In the first phase, participants will receive different doses of TYRA-300 to determine the most suitable dose. In the second phase, the study will focus on how effective TYRA-300 is at treating the tumors. Participants will be monitored for any side effects and changes in their health, including regular checks of their blood and heart function. The study will also look at how the body processes TYRA-300 over time.

Participants in this study will have tumors that have specific changes in the FGFR3 gene, which can be identified through tests. The study aims to gather information on how TYRA-300 affects these tumors and to explore any potential benefits it may offer. The trial is expected to continue until 2027, with the goal of improving treatment options for people with these types of cancer.

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 treatment phase
The study begins with the administration of the medication TYRA-300. This medication is taken orally in the form of a capsule or tablet.
The dosage and frequency of TYRA-300 will be determined based on the specific phase of the trial you are participating in. The initial phase focuses on determining the optimal dose and understanding how the body responds to the medication.
Step 2
Monitoring and evaluation
Throughout the trial, regular monitoring will occur to assess the body's response to TYRA-300. This includes checking vital signs, conducting blood tests, and performing physical examinations.
The study will also evaluate any side effects experienced and adjust the treatment plan as necessary to ensure safety and effectiveness.
Step 3
Dose adjustment phase
Based on the initial response and any side effects observed, the dosage of TYRA-300 may be adjusted. This phase aims to find the most effective dose with the least side effects.
The duration of this phase depends on individual response and the specific requirements of the trial phase.
Step 4
Extended treatment phase
Once the optimal dose is determined, the treatment continues with regular administration of TYRA-300 at the established dose.
This phase focuses on evaluating the long-term effects and benefits of the medication in managing the condition.
Step 5
Final assessment and follow-up
At the end of the trial, a comprehensive assessment will be conducted to evaluate the overall effectiveness of TYRA-300.
Follow-up visits may be scheduled to monitor any lasting effects and to gather additional data on the medication's impact.

Who can join the trial?

10 criteria

Participants must be 18 years of age or older.
Participants must have a life expectancy of more than 12 weeks.
Participants must be able to understand and sign the informed consent form (ICF) and follow study procedures.
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
Participants must have a confirmed advanced solid tumor with specific changes in the FGFR3 gene, which is a gene that can affect cell growth.
Participants must be able to swallow oral medications.
Participants must have at least one measurable lesion, which is a tumor that can be measured in size.
Participants must have adequate organ and bone marrow function, which includes specific blood counts and liver and kidney function tests.
Participants and their partners must agree to use effective contraception during the study and for a period after the study ends.
Participants must meet local COVID-19 testing and vaccination requirements.

Who cannot join the trial?

3 criteria

Patients with medical conditions other than **Advanced Urothelial Carcinoma** or other solid tumors with **activating FGFR3 gene alterations** cannot participate. **Urothelial Carcinoma** is a type of cancer that occurs in the urinary system, and **FGFR3 gene alterations** refer to specific changes in a gene that can affect cell growth.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so it's important to check if you fall within these ranges.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, such as those with certain disabilities or conditions.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Comite Entreprise Paul Papin
Verified
Angers, France
Hospital Universitario Quironsalud Madrid
Verified
Pozuelo De Alarcon, Spain
Hospital Vall d’Hebron
Verified
Barcelona, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

TYRA-300 is an investigational medication being studied for its potential to treat advanced urothelial carcinoma and other solid tumors that have specific changes in the FGFR3 gene. The study aims to find the best dose of TYRA-300 that can be safely given to patients and to see how well it works in shrinking or controlling tumors with these genetic changes.

Tyra-300-B01

What is already known about the treatment

TYRA-300 – TYRA-300 is an investigational medication administered orally, currently being studied in clinical trials for its potential use in treating advanced urothelial carcinoma and other solid tumors with specific genetic changes in the FGFR3 gene. It is in the early phases of clinical research, with ongoing studies to determine the optimal dosage and assess its effectiveness against tumors with these genetic alterations. The main therapeutic indication for TYRA-300 is for cancers that have FGFR3 gene changes, which are known to drive tumor growth. At the molecular level, TYRA-300 works by inhibiting the activity of the FGFR3 protein, which is involved in cell growth and division. It is classified pharmacologically as a targeted therapy, specifically an FGFR3 inhibitor.

Investigated diseases

Advanced Urothelial Carcinoma
This is a type of cancer that begins in the urothelial cells lining the bladder and other parts of the urinary tract. It is considered advanced when it has spread beyond the bladder to nearby tissues or distant organs. The disease often progresses by invading deeper layers of the bladder wall and can metastasize to lymph nodes, bones, liver, or lungs. Symptoms may include blood in the urine, frequent urination, and pain during urination. As the disease advances, it can lead to more severe symptoms and complications.
Solid Tumors with Activating FGFR3 Gene Alterations
These are a group of cancers characterized by the presence of mutations in the FGFR3 gene, which can lead to uncontrolled cell growth. Solid tumors can occur in various organs, including the bladder, cervix, and head and neck regions. The FGFR3 gene alterations can drive the progression of these tumors by promoting cell proliferation and survival. The disease may manifest with symptoms specific to the tumor's location, such as pain, swelling, or organ dysfunction. Over time, these tumors can grow larger and potentially spread to other parts of the body.