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

Trial ID: NCT06102525

Interventional - Phase 1/2 - Recruiting

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.

Conditions

• Glioblastoma

Interventions

• RZ-001
• VGCV

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

Sponsor

Rznomics, Inc.

Source: ClinicalTrials.gov

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