NCT06703255

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

A Phase IIa Clinical Study of HX301 Alone or in Combination with Temozolomide in Patients with High-Grade Glioma (Grade III and IV)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Hangzhou Hanx Biopharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will include a dose-escalation and dose-expansion component to establish the recommended Phase 2 dose (RP2D) for HX301 in combination with Temozolomide and to evaluate the preliminary antitumor activity of HX301.HX301 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes.

Conditions

• Glioma

Interventions

Type	Name	Description
DRUG	HX301+/Temozolomide	Part I: It is planned to firstly explore a dose of 160 mg and enroll approximately 3-6 subjects to receive HX301 monotherapy until disease progression, intolerable toxicity, or other reasons for stopping treatment for up to 24 cycles of 28 days each. Safety evaluation was performed using the traditional "3 + 3" rule, and the DLT observation period was 28 days (C1D1 \~ C1D28). If 160 mg was not tolerated, it was reduced to 120 mg for exploration. Part II: Combination therapy phase: HX301 will be administered in combination with temozolomide approximately 4-6 weeks after completion of chemoradiotherapy. The TMZ dose will follow the first cycle: 150 mg/m 2 qd D1-D5, starting with the second cycle, and if the criteria for TMZ dose increase are met, TMZ will be administered as 200 mg/m 2 qd D1-D5 every 2 8 days for up to 12 cycles. Monotherapy maintain period: Following the end of temozolomide treatment, HX301 monotherapy will be continued for a maximum of 12 cycles of 28 days each.

Timeline

• Start date: 2025-01-08
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-11-25
• Last updated: 2025-01-15

Locations

1 site across 1 country: China