Overview
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.
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.
Eligibility
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