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

RECRUITINGPhase 1/2Sponsored by Rznomics, Inc.
Actively Recruiting
PhasePhase 1/2
SponsorRznomics, Inc.
Started2024-10-08
Est. completion2029-03
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerGlioblastoma

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