Lirafugratinib for Solid Tumors
(ReFocus202 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called lirafugratinib to determine its safety and effectiveness for individuals with certain advanced solid tumors. The focus is on tumors that cannot be surgically removed and have a specific alteration in the FGFR2 gene, which is involved in cell growth. Participants should have previously tried other treatments and must have this FGFR2 gene change confirmed. Those with hard-to-treat tumors fitting this profile might find this trial suitable. As a Phase 2 trial, the research aims to measure the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that lirafugratinib is likely to be safe for humans?
Research has shown that lirafugratinib is generally safe for patients with solid tumors. In an earlier study, patients took a daily dose of 70 mg, and the treatment positively affected the tumors. Most importantly, the study found that patients did not experience severe side effects. Some experienced mild to moderate issues like tiredness and nausea, but these were manageable. Overall, the current data indicates that lirafugratinib has a favorable safety profile.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about lirafugratinib because it offers a new approach to treating solid tumors. Unlike traditional chemotherapy, which often targets all rapidly dividing cells, lirafugratinib is designed to specifically inhibit certain pathways that are crucial for tumor growth, potentially leading to fewer side effects. This targeted mechanism could mean more effective treatment with less collateral damage to healthy cells, making it a promising option for patients with solid tumors.
What evidence suggests that lirafugratinib might be an effective treatment for solid tumors?
Studies have shown that lirafugratinib, the treatment being tested in this trial, can effectively combat various solid tumors with FGFR2 changes. One study found that patients went nearly a year, with a median of 11.3 months, without their cancer worsening. The treatment also benefited almost half of the patients, with 46.5% experiencing tumor shrinkage or disappearance. Importantly, lirafugratinib has demonstrated lasting benefits, indicating its positive effects can persist over time. These results suggest that lirafugratinib may be effective for treating solid tumors with FGFR2 fusions or rearrangements.13567
Are You a Good Fit for This Trial?
Adults with advanced solid tumors (except cholangiocarcinoma) that can't be removed by surgery and have already been treated. These tumors must have a specific genetic change called FGFR2 fusion or rearrangement.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take lirafugratinib regularly as instructed by their study doctor and visit the clinic for checkups and tests
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lirafugratinib
Trial Overview
The trial is testing the effectiveness and safety of lirafugratinib, an oral medication. Participants will take it as prescribed, attend clinic visits for monitoring, and keep a diary of their dosage intake.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Treatment with standard dose of lirafugratinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Elevar Therapeutics
Lead Sponsor
Citations
Efficacy and safety of lirafugratinib in FGFRi-naïve ...
Conclusions: Lirafugratinib demonstrated clinically meaningful anti-tumor activity (ORR, DOR, and PFS), manageable and tolerable safety in CCA ...
2.
oncologynewscentral.com
oncologynewscentral.com/biliary-tract-cancer/lirafugratinib-produces-durable-responses-in-fgfr2-fusion-cholangiocarcinoma-trialLirafugratinib Produces Durable Responses in FGFR2 ...
The median progression-free survival was 11.3 months (95% CI, 9.2–14.8 months), with 49.2% of patients remaining progression-free at one year.
Tumor-agnostic efficacy and safety of lirafugratinib, a highly ...
+: Denotes censored time. • Lirafugratinib demonstrated durable clinical activity and radiographic response across 14 solid tumor types ...
4.
onclive.com
onclive.com/view/fda-approval-sought-for-lirafugratinib-in-second-line-fgfr2-altered-cholangiocarcinomaFDA Approval Sought for Lirafugratinib in Second-Line, ...
In this cohort, the objective response rate (ORR) was 46.5% (95% CI, 37.1%-56.1%). Best overall responses included a complete response (CR) rate ...
5.
cancernetwork.com
cancernetwork.com/view/lirafugratinib-displays-antitumor-activity-in-advanced-fgfr2-mutated-ccaLirafugratinib Displays Antitumor Activity in Advanced ...
Treatment with 70 mg of daily lirafugratinib displayed positive antitumor activity among patients previously treated for unresectable, ...
A Study of Lirafugratinib in Non-CCA Solid Tumors With ...
The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, ...
Discovery of lirafugratinib (RLY-4008), a highly selective ...
Existing targeted therapies for solid tumors harboring FGFR2 alterations include pan-FGFR inhibitors, which often cannot be dosed to maximum ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.