A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement
This phase 2 clinical trial is testing an experimental targeted drug called lirafugratinib. It is designed for adults with solid tumours that have spread to other parts of the body (metastatic) or cannot be removed using surgery (unresectable). To join, participants must have already tried standard cancer treatments and have tumours with a specific change in their genes known as an FGFR2 fusion or rearrangement. People with bile duct cancer (cholangiocarcinoma) are not eligible for this study. The main aim of the trial is to see how well lirafugratinib can shrink tumours or stop them from growing. Researchers will also closely monitor the drug's safety, side effects, and how it affects everyday quality of life. Because this is an open-label study, every participant receives the study medicine, and nobody receives a dummy treatment (placebo).
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¿De qué trata este estudio?
Cancer treatments are increasingly being tailored to the unique genetic features found inside tumour cells. In some solid tumours, a gene called FGFR2 can change or fuse with another gene. This faulty signal tells the cancer cells to grow and multiply rapidly. Lirafugratinib is an experimental medicine created to block these abnormal signals, which may slow down or stop the cancer from growing.
This study focuses on people with advanced solid cancers whose tumours have this specific FGFR2 change. It is designed for patients whose cancer has come back or continued to grow after standard treatments, and whose tumours cannot be safely operated on. By testing lirafugratinib specifically in this group, doctors hope to offer a targeted option when regular treatments have stopped working. However, this study does not include people with bile duct cancer, as that condition is being investigated separately.
As a phase 2 trial, the study aims to measure how effectively the drug shrinks tumours and how long that benefit lasts. It also checks how the body handles the drug, tracking side effects and ensuring that the treatment does not harm patients' daily quality of life. The findings will help doctors understand whether lirafugratinib could become an approved treatment option in the future.
Puntos clave
- A phase 2 trial testing the targeted medicine lirafugratinib.
- Open to adults with advanced solid tumours carrying an FGFR2 gene change.
- Designed for people whose cancer has already had standard treatment.
- Bile duct cancer (cholangiocarcinoma) is not included in this study.
- All participants receive the study medicine; there is no placebo.
¿Quién puede ser elegible?
This study is open to adults aged 18 and over who have an advanced or metastatic solid cancer that cannot be removed by surgery. To be considered, your cancer must have already been treated with standard therapies, such as chemotherapy or immunotherapy, that are no longer working.
Your tumour must also test positive for a specific genetic change known as an FGFR2 fusion or rearrangement. Your doctor or the study team can check your previous biopsy results or perform a test to see if your cancer has this feature. People diagnosed with bile duct cancer (cholangiocarcinoma) are not eligible for this trial.
In addition, you will need to meet basic health requirements, such as having reasonably good kidney, liver, and heart function, to ensure taking part is as safe as possible for you. The trial team will carry out health checks to confirm if the study is suitable.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- You are aged 18 or older.
- You have a solid cancer that has spread or cannot be removed by surgery.
- You have already received standard treatments for your cancer.
- Your tumour has an FGFR2 fusion or rearrangement.
- Your cancer is not bile duct cancer (cholangiocarcinoma).
¿En qué consiste la participación?
Taking part involves regular visits to a specialist hospital or clinical trial unit. You will be given lirafugratinib to take according to the trial schedule. During your visits, the research team will carry out health checks, including physical exams, blood tests, heart checks (ECGs), and imaging scans (such as CT or MRI scans) to see how your tumour is responding. You will also be asked to complete questionnaires about your daily wellbeing and quality of life. You will continue to take the medicine as long as it is helping you and any side effects remain manageable. After finishing the treatment, you will have safety follow-up visits so the team can continue to monitor your health.
Riesgos y beneficios potenciales
Ubicaciones (2)
- —No verificadoFrancia
- —No verificadoEspaña
Preguntas comunes
Will I receive a placebo (dummy pill) in this trial?
No. This is a 'single-arm' study, meaning everyone who takes part will receive the active study drug, lirafugratinib.
What is an FGFR2 fusion or rearrangement?
It is a specific genetic fault where the FGFR2 gene joins with another gene or changes position, sending signals that make cancer cells grow.
Why is bile duct cancer excluded from this study?
Bile duct cancer (cholangiocarcinoma) often has FGFR2 changes and is being studied in separate, dedicated clinical trials designed specifically for that condition.
How long will I be involved in the trial?
You will usually stay on the study for as long as the treatment is helping you and side effects are acceptable, followed by a period of safety check-ups.
Will I have to pay for the study treatment?
No. The study medicine and any extra trial-related tests are provided free of charge through the clinical trial.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.