RZ-001: Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of dose limiting toxicities (DLTs) — Day 1 to Day 28
Maximum tolerated dose (MTD) or maximum administered dose (MAD) dose(MAD) and select the recommended Phase 2 dose (RP2D) of RZ-001 in combination with VGCV — Day 1 to Day 28
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE — Day 1 to Day 28 Adverse events (AEs) as characterized by type, number, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\]), timing, seriousness, and relationship to RZ-001
Number of participants with significant laboratory abnormalities as assessed by NCI-CTCAE — Day 1 to Day 28 Clinically significant laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI-CTCAE), timing, and relationship to RZ-001
Overall survival (OS) — Day 1 to Day 15
Trial sites (6)
Facility
City
Region
Status
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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