A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Glioblastoma
- Registration Number
- NCT06102525
- Lead Sponsor
- Rznomics, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 43
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2 RZ-001 RZ-001 Dose 6 and VGCV Part 1 Cohort 5 RZ-001 RZ-001 Dose 5 and VGCV Part 1 Cohort 4 VGCV RZ-001 Dose 4 and VGCV Part 1 Cohort 5 VGCV RZ-001 Dose 5 and VGCV Part 2 VGCV RZ-001 Dose 6 and VGCV Part 1 Cohort 2 VGCV RZ-001 Dose 2 and VGCV Part 1 Cohort 3 VGCV RZ-001 Dose 3 and VGCV Part 1 Cohort 1 VGCV RZ-001 Dose 1 and VGCV Part 1 Cohort 1 RZ-001 RZ-001 Dose 1 and VGCV Part 1 Cohort 2 RZ-001 RZ-001 Dose 2 and VGCV Part 1 Cohort 3 RZ-001 RZ-001 Dose 3 and VGCV Part 1 Cohort 4 RZ-001 RZ-001 Dose 4 and VGCV
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as assessed by NCI-CTCAE Day 1 to Day 28 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
Number of participants with significant laboratory abnormalities as assessed by NCI-CTCAE Day 1 to Day 28 Clinically significant laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI-CTCAE), timing, and relationship to RZ-001
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 Day 1 to Day 28 Overall survival (OS) Day 1 to Day 15 Number of dose limiting toxicities (DLTs) Day 1 to Day 28
- Secondary Outcome Measures
Name Time Method Change in concentration of serum vascular endothelial growth factor (VEGF) Day 1 to Day 28 Overall response rate (ORR) Day 1 to Day 15 Duration of response (DOR) Day 1 to Day 15 Progression-free survival (PFS) per modified Response Assessment for Neuro-Oncology (mRANO) Day 1 to Day 15 Change in concentration of serum anti-adenovirus antibody Day 1 to Day 28 Overall survival (OS) Day 1 to Day 15 Neurologic function assessment using the Neurologic Assessment in Neuro-Oncology (NANO) scale ranging from 0 to 3 in each assessment domain Day 1 to Day 15
Trial Locations
- Locations (4)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of