NCT07138001

Phase 2 Clinical Trial of KH617

A Randomized, Controlled, Open-label, Multicenter Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of KH617 in Combination With Temozolomide Versus Investigator's Choice Treatment or KH617 Monotherapy for Recurrent Glioblastoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sichuan Honghe Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of KH617 for injection in combination with temozolomide versus investigator's choice therapy or KH617 monotherapy for recurrent glioblastoma

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	KH617+TMZ	use KH617 and TMZ(5/28) as Combination Product.
DRUG	KH617	Single Clinical trial investigational drug
DRUG	TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16	Comparator product, Two treatment options for physicians and subjects to choose from: 1. use TMZ(7/7) 2. Use Platinum (cisplatin or carboplatin)+VP-16

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-09-01
• Completion: 2030-12-01
• First posted: 2025-08-22
• Last updated: 2025-08-22