XRD-0394 + Radiation Therapy for Brain Tumor

This trial tests a new treatment, XRD-0394, combined with radiation therapy, for individuals with high-grade gliomas, which are aggressive brain tumors. The trial aims to determine the optimal dose of XRD-0394 for patients who have undergone surgery, are about to undergo surgery, or have recurring tumors. Participants must have a confirmed diagnosis of a high-grade glioma and meet specific criteria to handle treatment, such as not having received prior radiotherapy to the same region for newly diagnosed tumors. As an Early Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

The trial protocol does not specify if you must stop all current medications. However, if you are receiving anti-glioma therapy, you need to stop it 14 days before the first dose of XRD-0394 and can resume it at least 5 days after completing XRD-0394. Also, you cannot take drugs that strongly affect the CYP3A4 enzyme or BCRP within 14 days before the trial or during participation.

Research has shown that XRD-0394 has been tested with radiation therapy. In these studies, the treatment proved generally safe, with only about 11.4% of patients experiencing significant side effects. Most participants tolerated it well. XRD-0394 aims to enhance the effectiveness of radiation therapy in killing cancer cells. Although still in early testing stages, it has shown promise in lab tests and earlier studies. This is encouraging, but further research is needed to fully understand its safety and effectiveness in people.¹²³⁴⁵

Researchers are excited about XRD-0394 for brain tumors because it offers a new approach by enhancing the effects of radiation therapy. Unlike traditional treatments like chemotherapy and standalone radiation, XRD-0394 is a small molecule inhibitor that targets DNA repair mechanisms, potentially making cancer cells more susceptible to radiation damage. This dual-action method could lead to improved outcomes for patients by making the tumor cells less able to recover from radiation therapy. Additionally, the specific dosing regimens, including both pre-surgical and post-surgical applications, allow for personalized treatment plans that could optimize patient response based on their individual tumor characteristics.

Research has shown that XRD-0394 might enhance the effectiveness of radiation therapy for treating high-grade gliomas, a type of brain tumor. Studies have found that XRD-0394 helps kill more tumor cells when combined with radiation, both in lab tests and animal studies. This drug blocks certain proteins that enable cancer cells to repair themselves, thereby improving the efficacy of radiation treatment. In this trial, participants will enroll in different treatment arms to receive varying doses of XRD-0394 with radiation therapy, either before or after surgical resection, or without surgery for recurrent cases. Early results suggest that this combination could lead to better outcomes than radiation alone. Although data collection from human trials continues, these initial findings are promising for those considering participation in trials with XRD-0394.¹²³⁶⁷