In short
Clinical trials are investigating ULIXERTINIB in children with progressive, relapsed, or refractory pediatric low-grade glioma (pLGG). These studies look at how well ULIXERTINIB works in combination treatment plans and how safe and active the regimens are. The main goal is to find promising treatment options for this patient group.
Key points
- ULIXERTINIB is being studied in a Phase 1 clinical trial for children with progressive, relapsed, or refractory pediatric low-grade glioma (pLGG). The trial uses a multi-arm umbrella design, which means several treatment options are being explored in one study. Researchers want to find treatment regimens that are safe and active, including ULIXERTINIB in combination with other study drugs. The main outcomes are dose-limiting toxicities and best tumor response. This trial is authorised and plans to include 56 participants.
Clinical trials overview
The authorised trial listed here is a Phase I/II combination umbrella trial in children with progressive, relapsed, or refractory pediatric low-grade glioma (pLGG). The study is called EPILOGUE and is designed to find promising single-agent or combination treatment regimens for this patient group.
Who can participate
This trial is for pediatric patients with pLGG that is progressive, relapsed, or refractory. In simple terms, this means the tumor has grown, come back after treatment, or has not responded well to treatment.
Study design and treatment approach
The study is interventional, which means researchers give study treatment and then measure the results. It uses a multi-arm umbrella design, so several treatment paths are tested within one trial. The trial also uses an intra-individual dose escalation concept, meaning the dose may be increased step by step for each patient to help find the best dose for safety and activity.
ULIXERTINIB is listed as an oral study drug in this trial, and it is being studied with other treatments such as vinblastinsulfat Teva® and tovorafenib. The brief summary states that the aim is to identify promising single-agent or combination-based regimens and to reach the optimal dose for each patient.
What the trial measures
The main safety outcome is dose-limiting toxicity (DLT) of the combination treatment regimens. A DLT is a side effect serious enough to limit treatment dose.
The main activity outcome is best response, including complete response (CR) or partial response (PR), based on RAPNO-LGG criteria. These responses are assessed for each patient during the study treatment period, up to a maximum of 12 cycles, with checks every 8 weeks and central review.
Trial details at a glance
The trial is authorised, has a planned enrollment of 56 participants, and is in Phase 1. Its focus is on finding safe and active treatment combinations for children with pLGG whose disease is difficult to treat.