RecruitingPhase 1Phase 2NCT06102525

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

Sponsor

Rznomics, Inc.

Enrollment

43 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria4

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

Interventions

DRUGRZ-001

Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene

COMBINATION_PRODUCTVGCV

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.