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Phase 2 Clinical Trial of KH617

NCT07138001 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sichuan Honghe Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wenbin Li · Beijing Titan Hospital,Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2027-09-30
Completion
2030-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07138001 on ClinicalTrials.gov