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A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma - Trial NCT06102525

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.

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NCT06102525
Phase 1/2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06102525
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A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma
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

Study Focus

Glioblastoma

RZ-001

Interventional

drug

Sponsor & Location

Rznomics, Inc.

Timeline & Enrollment

Phase 1/2

Oct 01, 2023

May 01, 2029

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 brain
Malignant neoplasm: Brain, unspecified
Mesothelioma
Malignant neoplasm: Brain stem
Malignant neoplasm: Overlapping lesion of brain

Data Source

ClinicalTrials.gov

NCT06102525

Non-Device Trial