Not yet recruitingRare disease

Phase 2 Study of Lirafugratinib in Patients with Previously Treated Unresectable Advanced Solid Tumors with FGFR2 Fusion (Excluding Cholangiocarcinoma)

Fast replyInvestigationalNo placebo

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What is this trial about?

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

The study examines adults who have previously treated, unresectable (cannot be removed by surgery), locally advanced or metastatic (has spread to other parts of the body) solid tumors that are not cholangiocarcinoma and that carry a genetic change called FGFR2 fusion. The investigational oral medication Lirafugratinib is given in capsule form. The purpose of the study is to evaluate how effectively the drug can shrink or control the tumors.

Participants will take one 70 mg capsule by mouth each day for a period that may last several months. Throughout the study they will attend regular clinic visits where doctors will perform physical exams, blood tests, and imaging scans such as CT scans to measure tumor size using standardized criteria known as RECIST. The study will also monitor any side effects, track changes in quality of life, and record how long any tumor response lasts.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
After enrollment, take lirafugratinib as a 70 mg oral capsule according to the dosing schedule defined by the study protocol
The medication is taken by mouth; the exact frequency and duration are determined by the trial investigators and are followed for the entire treatment period
Step 2
Regular safety assessments
Attend scheduled clinic visits where laboratory tests, electrocardiograms (ecg), and vital‑sign measurements are performed
These assessments are used to monitor for treatment‑emergent adverse events (teaes) and other safety findings, which are evaluated according to the nci ctcae v5.0 grading system
Step 3
Tumor response evaluations
Undergo imaging studies at predefined intervals to assess tumor size and progression
The results are evaluated using the recist v1.1 criteria by an independent review committee (irc) to determine objective response rate (orr) and duration of response (dor)
Step 4
Dose modification considerations
If safety assessments indicate significant side effects, the study protocol may require dose interruption, dose reduction, or discontinuation of lirafugratinib
Any modifications are made according to the predefined rules in the trial protocol
Step 5
Continuation of therapy
Continue taking lirafugratinib as directed while safety and efficacy assessments remain within acceptable limits
Treatment proceeds until disease progression, unacceptable toxicity, or completion of the planned study duration
Step 6
Treatment completion and follow‑up
After the last dose, attend a final safety follow‑up visit where laboratory values, ecg, and vital signs are recorded
The follow‑up visit allows for collection of any late‑onset safety information and final assessment of treatment outcomes

Who can join the trial?

7 criteria

Willing and able to give informed consent (understand the study and agree in writing) before any study procedures.
Age 18 years or older, any gender.
Has a tumor that can be measured on scans using RECIST v1.1 (a standard set of rules doctors use to decide if a tumor is big enough to be measured).
Has a solid tumor that is unresectable (cannot be removed by surgery), locally advanced (has grown large but not spread far) or metastatic (has spread to other parts of the body), and the tumor shows an FGFR2 fusion or rearrangement (a specific genetic change) detected by DNA or RNA sequencing or a lab test called break‑apart fluorescence in situ hybridization (FISH).
Has previously received at least one line of systemic therapy (treatment that goes through the whole body) such as chemotherapy (drugs like gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved medicines, at least 30 days before joining the study.
Has not been treated before with an FGFR inhibitor (FGFRi) (a drug that targets the FGFR pathway).
Has an ECOG performance status of 0 or 1 (a scale that measures how well you can carry out daily activities; 0 = fully active, 1 = restricted but able to do light work).

Who cannot join the trial?

20 criteria

Uncontrolled comorbidity: A health problem that is not well‑controlled or stable (for example, uncontrolled diabetes or high blood pressure) makes you ineligible.
You have another type of cancer with a known genetic change that can be treated with an approved targeted drug (such as EGFR, ALK, ROS1, RET, HER2, BRAF, IDH1, KRAS). This excludes you unless special approval is obtained.
Your recent lab tests do not show adequate organ function. This includes low platelet count, low neutrophil count, low hemoglobin, liver enzymes that are too high, high bilirubin, poor kidney function, or high phosphate levels.
You have an active infection, including HIV, hepatitis B, or hepatitis C. HIV is the virus that causes AIDS; hepatitis B and hepatitis C are liver infections. Active infection excludes participation.
Your heart’s electrical activity shows a QT interval longer than 480 milliseconds, or you have a history of prolonged QT syndrome, Torsade de Pointes (a dangerous heart rhythm), or a family history of these conditions.
You have serious, uncontrolled heart problems such as severe heart failure (Class III or IV), a heart attack or unstable chest pain within the last 6 months, uncontrolled high blood pressure, or a serious irregular heartbeat that could affect the study drug.
You have cancer that has spread to the brain or spinal cord (central nervous system metastases) or a primary brain tumor that is causing worsening neurological symptoms or needs increasing doses of steroids.
You received any cancer treatment (chemotherapy, targeted therapy, or radiation) within 14 days (or five half‑lives, whichever is shorter) before the first dose, or immunotherapy/antibody therapy within 28 days. Half‑life is the time it takes for half of a drug to leave the body.
You had a liver‑directed treatment (such as transcatheter arterial chemoembolization or yttrium‑90 therapy) within 4 weeks before the first dose.
You received neutrophil growth factor support (medication that raises white blood cell counts) within 14 days of the first dose.
You need to take a medication that is not allowed in the study and cannot stop it at least five half‑lives or 2 weeks (whichever is shorter) before starting the study drug.
You had a major surgical procedure (excluding minor procedures like a central line placement or tumor needle biopsy) within 14 days before the first dose.
You have a history of another primary cancer that was diagnosed or required treatment within the past year, except for completely removed skin cancers (basal cell or squamous cell), cured localized prostate or breast cancer, cured localized thyroid cancer, or carcinoma in situ that was fully removed.
You are unwilling or unable to attend scheduled visits, take the medication as directed, have required laboratory tests, or follow any other study procedures.
If you are a female who is not postmenopausal (no periods for at least 12 months) or not surgically sterile (cannot have children), you must agree to avoid sexual intercourse or use highly effective birth control during treatment and for at least 6 months after the last dose. Male participants who are not surgically sterile must agree to the same during treatment and for at least 3 months after the last dose.
You are pregnant, as shown by a positive serum β‑hCG test (a blood test that detects the hormone made during pregnancy) taken within 7 days before the first dose.
You are breastfeeding.
You have any other significant medical condition, past surgery, physical finding, or lab abnormality that the doctor believes could affect your safety, how your body handles the study drug, or the study results.
You have a history of abnormal calcium deposits in the body (ectopic mineralization or calcification).
You are known to be allergic (systemic hypersensitivity) to lirafugratinib or any of its inactive ingredients.

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Verified sites

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

Centr Georges Francois Leclerc
Verified
Dijon, France
Centre Leon Berard
Verified
Lyon, France
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

Lirafugratinib is an oral capsule taken by mouth that is designed to block a specific protein called FGFR2, which can be abnormal in some advanced solid cancers. By inhibiting this protein, the drug aims to slow down or stop the growth of tumors that have an FGFR2 fusion or rearrangement. In this study, patients who have already received other treatments receive Lirafugratinib to see how well it works in shrinking or controlling their cancer. The medication is classified as an orphan drug, meaning it is intended for a rare condition.

What is already known about the treatment

Lirafugratinib - Lirafugratinib is taken orally as a 70 mg capsule and is given by swallowing the pill with water. It is currently an investigational orphan drug being studied in Phase 2 clinical trials for cancer treatment. The medication is intended for patients with previously treated, unresectable, locally advanced or metastatic solid tumors that have an FGFR2 fusion or rearrangement (excluding cholangiocarcinoma). It works by blocking the FGFR2 protein’s activity, which stops signals that help cancer cells grow, and it is classified as a small‑molecule FGFR inhibitor, a type of targeted cancer therapy.

Investigated diseases

FGFR2 fusion‑positive solid tumors - These are solid cancers that have a genetic change called an FGFR2 fusion or rearrangement. The tumors cannot be removed by surgery and have already been treated with other therapies. They may grow locally, extending into nearby tissues, or spread to distant parts of the body (metastatic). Over time, the disease can become more extensive as cancer cells continue to divide and move. The presence of the FGFR2 fusion drives the growth and spread of the tumor.