cropped color_logo_with_background.png

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.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Korea, Republic of
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 a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Gachon University Gil Medical Center, Incheon, Korea, Republic of

Status

Recruiting

Address

Gachon University Gil Medical Center

Incheon, , 21565

Site Contact

Gachon University Gil Medical Center

[email protected]

+82317068730

Seongnam-si, Korea, Republic of

Status

Recruiting

Address

Seoul National University Bundang Hospital

Seongnam-si, , 13620

Site Contact

Seoul National University Bundang Hospital

[email protected]

+82317068730

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 05505

Site Contact

Asan Medical Center

[email protected]

+82317068730

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 06351

Site Contact

Samsung Medical Center

[email protected]

+82317068730