drugset / Trial / NCT06703255

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

NCT06703255

Phase 1/2 Recruiting 72 enrolled Hangzhou Hanx Biopharmaceuticals, Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-08
Primary completion
2026-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Narazaciclib Small molecule 120 mg
Subject Narazaciclib Small molecule 160 mg
Subject Temozolomide Small molecule 150 mg/m2
Subject Temozolomide Small molecule 200 mg/m2

Indications