drugset / Trial / NCT05346484
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab or mFOLFOX in patients with metastatic or advanced solid tumors.
Timeline
- Start
- 2022-05-17
- Primary completion
- 2026-01-12
- Completion
- 2026-01-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CF33-hNIS | Unknown | — | Intrathecal |
| Subject | Leucovorin | Small molecule | — | — |
| Subject | Oxaliplatin | Small molecule | — | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | fluorouracil | Small molecule | — | — |