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NCT Number: NCT06102525

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

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Gachon University Gil Medical Center, Incheon, South Korea

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About this study

The study consists of 2 parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2).

Part 1 consists of dose escalation exploring MTD/RP2D for intratumoral (IT) injection.

Part 2 will consist of dose expansion exploring clinical activity for the optimal fixed dose based on the results of Part 1.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RZ-001

Drug

Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene

Other names: Ad-ECRT-122T

VGCV

Combination Product

VGCV, used in a subject after RZ-001 administration, is a nucleoside analog that is metabolized by HSV-tk and other cellular kinases to form the cytotoxic nucleotide analog ganciclovir triphosphate. An approved oral VGCV will be used in the proposed clinical study of RZ-001.

Other names: Valganciclovir

Primary outcomes

  1. Number of dose limiting toxicities (DLTs)

    Time frame: Day 1 to Day 28

  2. 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

    Time frame: Day 1 to Day 28

  3. Number of participants with treatment-related adverse events as assessed by NCI-CTCAE

    Time frame: Day 1 to Day 28

    Adverse events (AEs) as characterized by type, number, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE]), timing, seriousness, and relationship to RZ-001

  4. Number of participants with significant laboratory abnormalities as assessed by NCI-CTCAE

    Time frame: Day 1 to Day 28

    Clinically significant laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI-CTCAE), timing, and relationship to RZ-001

  5. Overall survival (OS)

    Time frame: Day 1 to Day 15

Secondary outcomes

  1. Change in concentration of serum vascular endothelial growth factor (VEGF)

    Time frame: Day 1 to Day 28

  2. Change in concentration of serum anti-adenovirus antibody

    Time frame: Day 1 to Day 28

  3. Overall response rate (ORR)

    Time frame: Day 1 to Day 15

  4. Duration of response (DOR)

    Time frame: Day 1 to Day 15

  5. Progression-free survival (PFS) per modified Response Assessment for Neuro-Oncology (mRANO)

    Time frame: Day 1 to Day 15

  6. Overall survival (OS)

    Time frame: Day 1 to Day 15

  7. Neurologic function assessment using the Neurologic Assessment in Neuro-Oncology (NANO) scale ranging from 0 to 3 in each assessment domain

    Time frame: Day 1 to Day 15

Other outcomes

  1. Concentration of adenovirus DNA in Plasma at specified timepoints

    Time frame: Day 1 to Day 28

  2. Change in concentration of serum anti-adenovirus antibody

    Time frame: Day 1 to Day 28

  3. Change in concentration of serum cytokines

    Time frame: Day 1 to Day 28

    Serum cytokines including interleukins 1 (IL-1), IL-6, IL-10, IL-27, interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α)

  4. Concentration of biomarker in peripheral blood

    Time frame: Day 1 to Day 28

    Activation of immune cell subsets (including but not limited to cluster of differentiation 3 [CD3], CD4, CD8, B cell, natural killer [NK] cell)

  5. Concentration of biomarker in fresh tumor biopsy tissue

    Time frame: Day 1 to Day 28

    Tumor-related RNA and T cell infiltration and activation

Study contacts

Contact information is provided by the study sponsor or research team.

Rznomics Inc.

CONTACT

[email protected]

+82317068730

Sponsors and collaborators

Lead sponsor

Rznomics, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 26, 2023
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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