FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration

Launched by SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD. · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called FCN-159 to see how well it works compared to standard chemotherapy in children with low-grade gliomas that have specific genetic changes, known as BRAF alterations. The goal is to find out if FCN-159 can help these patients, who are between 2 and 17 years old, by looking at how effective and safe it is for their condition.

To be eligible for this trial, participants need to have a confirmed diagnosis of low-grade glioma and show the particular BRAF alteration. They also need to have measurable tumors and require treatment due to factors like disease progression or residual tumors after surgery. Throughout the trial, participants will receive either FCN-159 or the chemotherapy chosen by their doctor, and doctors will monitor their health closely to gather important information about how the treatments work. It’s important for families to know that this trial is not yet recruiting participants, meaning they will not be able to enroll just yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Pediatric patients aged between ≥ 2 years and \< 18 years; regardless of male or female.
• • 2. Histologically and/or cytologically confirmed diagnosis of low-grade glioma (pLGG diagnosis as Grade 1 or 2 according to the 2021 WHO classification of CNS).
• • 3. KIAA1549-BRAF fusion or BRAF V600E mutation-positive.
• • 4. Patients requiring systemic therapy as determined by the investigator, including patients having disease recurrence or progression, or residual disease of surgery, or unresectable.
• • 5. At least one intracranial measurable lesion that can be reproducibly measured in two dimensions on T2-FLAIR, with the minimum size of the bi-perpendicular diameter of ≥ 10 mm, and can be visible on two or more imaging slice.
• • 6. Karnofsky performance score or Lansky performance score ≥ 70. 7．Adequate organ function within 14 days before enrollment.
• Exclusion Criteria:
• 1. Patients who have previously received any of the following treatments:
• • 1. Patients who have received chemotherapy drugs or traditional Chinese medicines or herbals with definitive anti-tumor treatment within 4 weeks preceding the first dose of investigational drug;
• • 2. Patients who have received growth factors that promote platelet or leukocyte count or function within 14 days preceding the first dose of investigational drug;
• • 3. Patients who received radiotherapy, surgery or immunotherapy within 4 weeks preceding the first dose of investigational drug;
• • 4. Patients who have participated in other interventional clinical trials within 4 weeks before receiving the first dose of investigational drug;
• • 5. Patients who have received live vaccines within 4 weeks preceding the first dose of investigational drug, or patients who have received inactivated vaccines and mRNA vaccines within 14 days preceding the study treatment;
• • 6. Patients who have previously received any other MEK 1/2 inhibitors such as Selumetinib or BRAF inhibitors such as Dabrafenib.
• • 2. Patients with high-grade gliomas, as well as schwannoma, subependymal giant cell astrocytoma (tuberous sclerosis), and diffuse intrinsic pontine gliomas (even if the histological diagnosis is WHO Grade 1 or 2).
• • 3. Patients who require endotracheal intubation for assisted ventilation or tracheotomy should be excluded.
• • 4. Patients who have uncontrollable epilepsy as assessed by the investigator.
• • 5. Patients with dysphagia, active GI diseases, malabsorption syndrome, or other conditions that will interfere with the absorption of the investigational drug.
• • 6. Patients with clinically significant active bacterial, fungal or viral infections, including hepatitis B virus surface antigen positive and hepatitis B virus DNA exceeding 1000 IU/ml. Hepatitis B carriers are allowed to be enrolled. Patients with positive hepatitis C virus (HCV) antibody test; those who have confirmed human immunodeficiency virus (HIV) infection, and are unwilling to undergo HIV testing.
• • 7. Patients with history or current evidence of retinal vein obstruction (RVO), retinal pigment epithelial detachment (RPED), central retinal vein occlusion, glaucoma, and other significant abnormalities in ophthalmological examinations.
• • 8. Interstitial pneumonia, including clinically significant radiation pneumonitis.
• • 9. Grade 3 creatine phosphokinase increased (\>5 × ULN - 10 × ULN).