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NOT YET RECRUITING
NCT07138001
PHASE2

Phase 2 Clinical Trial of KH617

Sponsor: Sichuan Honghe Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-08

Completion Date

2030-12

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

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