Phase IIa Study of HX301 Alone or With Temozolomide for Adults with High-Grade Glioma Grade III and IV

What this Trial Is About

Researchers are conducting a Phase IIa clinical study to evaluate the investigational drug HX301 alone or combined with Temozolomide in patients with high-grade glioma Grade III and IV. The study aims to find the recommended dose for Phase 2 and assess preliminary antitumor activity. HX301 is not yet approved by regulatory authorities and is being studied for its safety and effectiveness in this patient group. The study includes two parts Part I explores HX301 monotherapy with dose escalation, starting at 160 mg and possibly reducing to 120 mg if needed, given in cycles of 28 days for up to 24 cycles. Part II evaluates HX301 combined with Temozolomide after chemoradiotherapy, with Temozolomide given in cycles of 150 mgm2 daily for 5 days initially, possibly increasing to 200 mgm2 for up to 12 cycles. After Temozolomide, participants continue HX301 monotherapy for up to 12 additional cycles. Participants will undergo safety monitoring, including tracking adverse events, and assessments of tumor response using RANO criteria during the 24 cycles. The study measures progression-free survival, objective response rate, and overall survival. Safety evaluations cover all adverse events during and up to 28 days after treatment. The total participation may extend through multiple treatment cycles, with careful follow-up and protocol compliance required.

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