Evaluating RZ-001 with Valganciclovir for 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
PHASE1; PHASE2 · Rznomics, Inc. · NCT06102525
This study is testing a new treatment combining RZ-001 and Valganciclovir to see if it can help people with a specific type of brain cancer called glioblastoma.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rznomics, Inc. (other) |
| Locations | 6 sites (Incheon and 5 other locations) |
| Trial ID | NCT06102525 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2a study aims to assess the safety, tolerability, and preliminary efficacy of RZ-001 in combination with Valganciclovir (VGCV) for patients with hTERT-positive glioblastoma. The study is divided into two parts: the first part involves dose escalation to determine the maximum tolerated dose for intratumoral injection, while the second part focuses on expanding the dose to evaluate clinical activity based on findings from the first part. Participants will be closely monitored for safety and immune response.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically-confirmed grade 4 astrocytoma or glioblastoma who are hTERT positive and meet specific health criteria.
Not a fit: Patients with other malignant tumors, extracranial metastases, or a history of HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with glioblastoma, potentially improving survival rates.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in targeting glioblastoma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Incheon and 5 other locations
- The Catholic University of Korea, Incheon St. Mary's Hospital — Incheon, South Korea (RECRUITING)
- Gachon University Gil Medical Center — Incheon, South Korea (RECRUITING)
- Seoul National University Bundang Hospital — Seongnam-si, South Korea (RECRUITING)
- Severance Hospital, Yonsei University Health System — Seoul, South Korea (RECRUITING)
- Asan Medical Center — Seoul, South Korea (RECRUITING)
- Samsung Medical Center — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Rznomics Inc.
- Email: rznomics@rznomics.com
- Phone: +82317068730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioblastoma