RecruitingPHASE2INTERVENTIONAL

A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement

This research study is investigating a new treatment called lirafugratinib. It’s for adults who have advanced solid cancers, excluding a type of liver cancer (cholangiocarcinoma), that have a specific genetic change in their FGFR2 gene. These patients will have already tried other treatments without success, and their cancer can't be removed by surgery. The main aim is to see if lirafugratinib is effective and safe. Participants will take the medication regularly, attend clinic visits for check-ups and tests, and keep a diary of their medication doses. This study hopes to find a new option for people living with these specific types of cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Elevar Therapeutics

Enrolment target

Start

01 May 2026

Estimated completion

01 Dec 2028

FGFR2 Gene Fusion/Rearrangement Other Solid Tumors, Adult

What is this study about?

This study is exploring a new medicine called lirafugratinib. It's for adult patients who have certain types of solid cancer that have become quite advanced, meaning they've spread or can't be removed surgically. Specifically, this study is for cancers that show a particular change in a gene called FGFR2. This change, known as a fusion or rearrangement, is important because the new medicine, lirafugratinib, is designed to target this specific genetic alteration.

Patients taking part in this study will have already tried at least one other type of cancer treatment, such as chemotherapy or immunotherapy, which hasn't worked as hoped. This study aims to find out if lirafugratinib can be an effective and safe new option for these patients. It's an important step in developing new treatments for cancers with specific genetic markers, moving towards more personalised medicine.

By carefully studying how lirafugratinib works in a group of patients, researchers hope to understand its potential benefits and any side effects. The information gathered will help determine if this medication could become a widely available treatment in the future for people living with these specific cancers.

Key takeaways

Targets specific FGFR2 gene changes in advanced solid cancers.
For adults who have already tried other cancer treatments.
Involves taking a new medication and regular clinic visits.
Aims to assess both the effectiveness and safety of a new drug.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have a solid cancer that has spread or can't be removed by surgery. It's important that your cancer has a specific change in the FGFR2 gene, which will be identified through blood or tumour tests. You must also have already received at least one other treatment for your cancer, like chemotherapy, and not previously taken a similar type of medication.

There are also some important health requirements. You should be generally well enough to take part, with most of your normal daily activities unaffected by your illness. Your body's organs, like your liver and kidneys, need to be working adequately. You cannot have uncontrolled infections, certain heart conditions, or progressive brain tumours or spread of cancer to the brain causing symptoms.

The study team will carefully check all your medical information to see if you meet all the criteria for taking part. This ensures the study is as safe and effective as possible for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a solid cancer that has spread or cannot be removed by surgery (not cholangiocarcinoma)?
Have tests shown a specific FGFR2 gene change in your cancer?
Have you already received at least one other treatment for your cancer?
Are you generally well enough to take part in a study?
Have you *not* received treatment with a similar FGFR-targeting drug before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medication, lirafugratinib, to take regularly, exactly as instructed by your study doctor. You'll need to keep a diary to record every time you take your dose. You will also have regular visits to the clinic for check-ups, which will include various tests to monitor your health and how the medication is working. The study team will explain the schedule for these visits and tests. The total duration of your participation will depend on how you respond to the treatment and will be discussed fully before you join.

Potential risks and benefits

Taking part in this study could offer the potential benefit of accessing a new treatment that might help with your cancer, especially if other treatments haven't worked. However, like all medications, lirafugratinib may have side effects, and these will be carefully monitored by the study team. There's also no guarantee that the treatment will be effective for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (19)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mayo Clinic
Verified postcode
Phoenix, United States· Not yet recruiting
Mayo Clinic
Verified postcode
Jacksonville, United States· Not yet recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
University of Chicago Medical Center
Verified postcode
Chicago, United States· Not yet recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Not yet recruiting
Mayo Clinic
Verified postcode
Rochester, United States· Not yet recruiting
The University of Texas M.D. Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Institut Bergonie
Verified postcode
Bordeaux, France· Not yet recruiting
Centre Georges François Leclerc
Verified postcode
Dijon, France· Not yet recruiting
Centre Leon Berard
Verified postcode
Lyon, France· Not yet recruiting
Gustave Roussy Cancer Campus
Verified postcode
Paris, France· Not yet recruiting
Seoul National University Hospital
Verified postcode
Seoul, South Korea· Recruiting

Common questions

What is an FGFR2 gene fusion or rearrangement?

It's a specific change in your cancer's genetic material. This change can make the cancer grow, and the study medication aims to target it.

What does 'unresectable, locally advanced, or metastatic' mean?

This means your cancer either can't be removed with surgery, is growing into nearby tissues, or has spread to other parts of your body.

Will I still receive my regular cancer care if I join the study?

Yes, your study doctor will oversee your care, and your other medical needs will continue to be met.

What are the common side effects of lirafugratinib?

The study aims to understand the side effects. All potential side effects will be discussed in detail by the study team before you decide to participate.

How long will I be on the study medication?

The duration varies for each person and depends on how you respond to the treatment. The study team will explain this to you.

How to find out more

Jacki Dillingham

jdillingham@elevartx.com +1 (385) 276-3611 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.