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Recruiting NCT06102525

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

Phase I / Phase II Interventional Glioblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RZ-001, VGCV.
Who it may be relevant to
Registry conditions: Glioblastoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

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.

Interventions

  • Drug RZ-001
    Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene
  • Combination product VGCV
    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.

Primary outcome measures

  • Number of dose limiting toxicities (DLTs) [Time frame: Day 1 to Day 28]
  • 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]
  • Number of participants with treatment-related adverse events as assessed by NCI-CTCAE [Time frame: Day 1 to Day 28]
  • Number of participants with significant laboratory abnormalities as assessed by NCI-CTCAE [Time frame: Day 1 to Day 28]
  • Overall survival (OS) [Time frame: Day 1 to Day 15]
Secondary outcome measures (7)
  • Change in concentration of serum vascular endothelial growth factor (VEGF) [Time frame: Day 1 to Day 28]
  • Change in concentration of serum anti-adenovirus antibody [Time frame: Day 1 to Day 28]
  • Overall response rate (ORR) [Time frame: Day 1 to Day 15]
  • Duration of response (DOR) [Time frame: Day 1 to Day 15]
  • Progression-free survival (PFS) per modified Response Assessment for Neuro-Oncology (mRANO) [Time frame: Day 1 to Day 15]
  • Overall survival (OS) [Time frame: Day 1 to Day 15]
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 6 centers
  • The Catholic University of Korea, Incheon St. Mary's Hospital — Incheon
  • Gachon University Gil Medical Center — Incheon
  • Seoul National University Bundang Hospital — Seongnam-si
  • Severance Hospital, Yonsei University Health System — Seoul
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT06102525 · RZ-001-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗