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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06102525
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rznomics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Doo Sik KongChang Ki Hong
Principal Investigator Affiliation	Samsung Medical CenterAsan Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Part 1 Cohort 1

RZ-001 Dose 1 and VGCV

Experimental: Part 1 Cohort 2

RZ-001 Dose 2 and VGCV

Experimental: Part 1 Cohort 3

RZ-001 Dose 3 and VGCV

Experimental: Part 1 Cohort 4

RZ-001 Dose 4 and VGCV

Experimental: Part 1 Cohort 5

RZ-001 Dose 5 and VGCV

Experimental: Part 2

RZ-001 Dose 6 and VGCV

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Rznomics Inc.

[email protected]

+82317068730

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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