A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma
NCT ID: NCT06102525
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
43 participants
INTERVENTIONAL
2024-10-08
2029-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 Cohort 1
RZ-001 Dose 1 and VGCV
RZ-001
Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene
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.
Part 1 Cohort 2
RZ-001 Dose 2 and VGCV
RZ-001
Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene
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.
Part 1 Cohort 3
RZ-001 Dose 3 and VGCV
RZ-001
Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene
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.
Part 1 Cohort 4
RZ-001 Dose 4 and VGCV
RZ-001
Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene
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.
Part 1 Cohort 5
RZ-001 Dose 5 and VGCV
RZ-001
Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene
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.
Part 2
RZ-001 Dose 6 and VGCV
RZ-001
Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene
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.
Interventions
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RZ-001
Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Have extracranial metastases of the tumor cells
* Current or history of HIV positive
* Not suitable for inclusion judged by the investigator
18 Years
ALL
No
Sponsors
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Rznomics, Inc.
OTHER
Responsible Party
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Locations
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The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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The Catholic University of Korea, Incheon St. Mary's Hospital
Role: primary
Gachon University Gil Medical Center
Role: primary
Seoul National University Bundang Hospital
Role: primary
Severance Hospital, Yonsei University Health System
Role: primary
Asan Medical Center
Role: primary
Samsung Medical Center
Role: primary
Other Identifiers
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RZ-001-201
Identifier Type: -
Identifier Source: org_study_id
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