A Phase 1/2a, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, and Efficacy of RZ-001 in Combination With Valganciclovir in Subjects With Glioblastoma
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug, Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Gachon University Gil Medical Center
RECRUITING
Incheon
The Catholic University of Korea, Incheon St. Mary's Hospital
RECRUITING
Incheon
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Contact Information
Primary
Rznomics Inc.
rznomics@rznomics.com
+82317068730
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2029-05
Participants
Target number of participants: 43
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Rznomics, Inc.