Evaluating RZ-001 with Valganciclovir for Glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2a study aims to assess the safety, tolerability, and preliminary efficacy of RZ-001 in combination with Valganciclovir (VGCV) for patients with hTERT-positive glioblastoma. The study is divided into two parts: the first part involves dose escalation to determine the maximum tolerated dose for intratumoral injection, while the second part focuses on expanding the dose to evaluate clinical activity based on findings from the first part. Participants will be closely monitored for safety and immune response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult males and females
* Histologically-confirmed grade 4 astrocytoma, GBM, per The 2021 WHO Classification of CNS Tumors.
* hTERT positive expression confirmed during the screening period
* ECOG score of ≤ 2
* KPS ≥ 60
* Life expectancy ≥ 3 months

Exclusion Criteria:

* Diagnosis of other malignant tumors within 5 years prior to RZ-001 administration.
* Have extracranial metastases of the tumor cells
* Current or history of HIV positive
* Not suitable for inclusion judged by the investigator

Where it's running

• The Catholic University of Korea, Incheon St. Mary's Hospital
  Incheon, South Korea Recruiting
• Gachon University Gil Medical Center
  Incheon, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seongnam-si, South Korea Recruiting
• Severance Hospital, Yonsei University Health System
  Seoul, South Korea Recruiting
• Asan Medical Center
  Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Rznomics Inc.
• Email: rznomics@rznomics.com
• Phone: +82317068730

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.