Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06102525

A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma

Led by Rznomics, Inc. · Updated on 2025-09-05

43

Participants Needed

6

Research Sites

238 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase 1/2a, open-label study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of RZ-001 administered in combination with VGCV in subjects with hTERT-positive GBM.

CONDITIONS

Official Title

A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult males and females
  • Histologically confirmed grade 4 astrocytoma or glioblastoma per 2021 WHO Classification of CNS Tumors
  • Positive hTERT expression confirmed during screening
  • ECOG performance status score of 2 or less
  • Karnofsky Performance Status (KPS) of 60 or higher
  • Life expectancy of at least 3 months
Not Eligible

You will not qualify if you...

  • Diagnosis of other malignant tumors within 5 years before RZ-001 administration
  • Presence of extracranial metastases from tumor cells
  • Current or past HIV positive status
  • Deemed unsuitable for study participation by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, South Korea, 21431

Actively Recruiting

2

Gachon University Gil Medical Center

Incheon, South Korea, 21565

Actively Recruiting

3

Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13620

Actively Recruiting

4

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

5

Asan Medical Center

Seoul, South Korea, 05505

Actively Recruiting

6

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

R

Rznomics Inc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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