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Trial Title:
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Glioblastoma
NCT ID:
NCT06102525
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Valganciclovir
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RZ-001
Description:
Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a
therapeutic transgene
Arm group label:
Part 1 Cohort 1
Arm group label:
Part 1 Cohort 2
Arm group label:
Part 1 Cohort 3
Arm group label:
Part 1 Cohort 4
Arm group label:
Part 1 Cohort 5
Arm group label:
Part 2
Other name:
Ad-ECRT-122T
Intervention type:
Combination Product
Intervention name:
VGCV
Description:
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.
Arm group label:
Part 1 Cohort 1
Arm group label:
Part 1 Cohort 2
Arm group label:
Part 1 Cohort 3
Arm group label:
Part 1 Cohort 4
Arm group label:
Part 1 Cohort 5
Arm group label:
Part 2
Other name:
Valganciclovir
Summary:
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Gachon University Gil Medical Center
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seoul National University Bundang Hospital
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Asan Medical Center
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Samsung Medical Center
Start date:
October 8, 2024
Completion date:
May 2029
Lead sponsor:
Agency:
Rznomics, Inc.
Agency class:
Other
Source:
Rznomics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102525
