What this Trial Is About

Researchers are studying HX301, an investigational drug not yet approved by the FDA, in patients with high-grade glioma (grade III and IV). This Phase 2a clinical trial aims to find the recommended dose of HX301 alone and in combination with temozolomide, and to evaluate the early antitumor effects of HX301. The study includes patients with recurrent or progressive disease after prior treatments and those newly treated with surgery and chemoradiotherapy for glioblastoma. The study has two parts. Part I explores HX301 monotherapy starting at 160 mg with 3-6 patients treated for up to 24 cycles of 28 days each, adjusting dose if needed based on safety. Part II combines HX301 with temozolomide following chemoradiotherapy, with temozolomide given in cycles of 28 days for up to 12 cycles at specified doses. After temozolomide treatment, HX301 alone continues for up to 12 more cycles. Safety and dosing are closely monitored throughout. Participants will undergo regular assessments including adverse event monitoring up to 28 days after treatment, brain MRI scans, and evaluations of tumor response and progression using established criteria. The study measures progression-free survival and objective response rates over 24 cycles of 28 days each. Participants need to be able to comply with the study schedule and have good performance status. The total participation duration can be up to approximately two years depending on treatment cycles.

A Phase 2 Study of HX301 in Patients with High-grade Giloma