Status:
RECRUITING
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma
Lead Sponsor:
Rznomics, Inc.
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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-po...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06102525
Start Date
October 8 2024
End Date
May 1 2029
Last Update
September 5 2025
Active Locations (6)
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1
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, South Korea, 21431
2
Gachon University Gil Medical Center
Incheon, South Korea, 21565
3
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
4
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722