NCT06102525RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma
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
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 23 Jun 2023
- Start date
- Oct 2024
- Primary completion date
- Mar 2029
- Lead sponsor
- Rznomics, Inc.
- Diseases
- Glioblastoma
- NCT number
- NCT06102525
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 43
- From Oct 2024 to the primary completion date, Mar 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of other malignant tumors within 5 years prior to RZ-001 administration.
Other illness
- Current or history of HIV positive
Other
- Have extracranial metastases of the tumor cells
- Not suitable for inclusion judged by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Catholic University of Korea, Incheon St. Mary's Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.