NCT06102525

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

Name: Clinical Trial NCT06102525
Creator: Rznomics, Inc.
Keywords: Glioblastoma, RZ-001, Phase 1/2, drug, clinical trial

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

Rznomics, Inc.·Phase 1/2·ClinicalTrials.gov·drugNot yet recruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Glioblastoma
Drug/Device/Intervention: RZ-001
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Rznomics, Inc.

Timeline & enrollment

Phase: Phase 1/2
Start date: Oct 01, 2023
End date: May 01, 2029
Enrollment: 43 participants

Primary outcome

Number of dose limiting toxicities (DLTs),Maximum tolerated dose (MTD) or maximum administered dose (MAD) dose(MAD) and select the recommended Phase 2 dose (RP2D) of RZ-001 in combination with VGCV,Number of participants with treatment-related adverse events as assessed by NCI-CTCAE,Number of participants with significant laboratory abnormalities as assessed by NCI-CTCAE,Overall survival (OS)

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.

ICD-10 classifications

Malignant neoplasm of brainMalignant neoplasm: Brain, unspecifiedMesotheliomaMalignant neoplasm: Brain stemMalignant neoplasm: Overlapping lesion of brain

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06102525
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06102525 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Rznomics, Inc. and is currently Not yet recruiting. The study focuses on Glioblastoma. Target enrollment is 43 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.