NCT06102525

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

A Phase 1/2a, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, and Efficacy of RZ-001 in Combination With Valganciclovir in Subjects With Glioblastoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Rznomics, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study consists of 2 parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). Part 1 consists of dose escalation exploring MTD/RP2D for intratumoral (IT) injection. Part 2 will consist of dose expansion exploring clinical activity for the optimal fixed dose based on the results of Part 1.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	RZ-001	Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene
COMBINATION_PRODUCT	VGCV	VGCV, used in a subject after RZ-001 administration, is a nucleoside analog that is metabolized by HSV-tk and other cellular kinases to form the cytotoxic nucleotide analog ganciclovir triphosphate. An approved oral VGCV will be used in the proposed clinical study of RZ-001.

Timeline

• Start date: 2024-10-08
• Primary completion: 2029-03-01
• Completion: 2029-05-01
• First posted: 2023-10-26
• Last updated: 2025-09-05

Locations

6 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study