A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma

• Status: Not yet recruiting
• Trial end date: 2029-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rznomics, Inc.
• Treatments: Valganciclovir

Criteria

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