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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Hospital Quironsalud Barcelona	Barcelona	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hurhimft Vxql dtyzwdcq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.03.2023
Italy	Not recruiting	31.03.2023
Spain	Not recruiting	31.03.2023

Trial locations

Investigated drugs:

Tyra-300-B01

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.

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.

Trial ID:

2023-507589-22-00

Protocol code:

TYR300-101

NCT ID:

NCT05544552

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

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