Clinical trial · Interventional
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
NCT06102525CI-TRIAL-00094580recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RZ-001 | Drug | — | UNRESOLVED |
| VGCV | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Part 1 Cohort 1
- description
- RZ-001 Dose 1 and VGCV
- interventionNames
- Drug: RZ-001
- Combination Product: VGCV
- type
- EXPERIMENTAL
- label
- Part 1 Cohort 2
- description
- RZ-001 Dose 2 and VGCV
- interventionNames
- Drug: RZ-001
- Combination Product: VGCV
- type
- EXPERIMENTAL
- label
- Part 1 Cohort 3
- description
- RZ-001 Dose 3 and VGCV
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.