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

Phase 2RecruitingNCT06102525

Rznomics, Inc.43 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma

Interventions

RZ-001DRUG

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

VGCVCOMBINATION_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Outcomes

Primary Outcomes

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

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

Time frame: Day 1 to Day 28

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

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

Time frame: Day 1 to Day 28

Overall survival (OS)

Time frame: Day 1 to Day 15

Secondary Outcomes

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

Central Contacts

Rznomics Inc.

CONTACT

+82317068730 rznomics@rznomics.com

Data from ClinicalTrials.gov

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