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New treatment option for FGFR2 Gene Fusion/Rearrangement
Official title A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
ClinicalTrials.gov ID: NCT07359820
What this study is testing
What is Lirafugratinib?
Lirafugratinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for fgfr2 gene fusion/rearrangement.
Also referred to as RLY-4008.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: Take lirafugratinib regularly as instructed by their study doctor.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Unresectable, locally advanced, or metastatic solid tumor (other than CCA).
- Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor.
- Patient must have measurable disease per RECIST v1.1 Patient has ECOG performance status of 0-1.
- Previously (\>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation...
- Subject has not received prior treatment with an FGFRi.
You likely can't join if
- An uncontrolled comorbidity.
- Patient does not have adequate organ function (defined in protocol).
- Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in...
- QT interval corrected using Fridericia's formula (QTcF) \> 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of...
- Clinically significant, uncontrolled cardiovascular disease.
- CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Houston, Texas, United States
- Bordeaux, France
- Dijon, France
- Lyon, France
- Paris, France
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
- London, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.