drugset / Trial / NCT06497010
An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
Phase 0
Recruiting
40 enrolled
The Affiliated Hospital Of Guizhou Medical University
Innovac Therapeutics · collab
NaSequentialOpen-labelTreatment
Summary
This is an open-label, prospective, exploratory clinical study, which is divided into two phases: dose escalation phase (Phase Ia) and expansion phase (Phase Ib). After completing the dose-escalation phase (Stage Ia) (5-11 patients), the investigator will select the dose group (RP2D) based on safety, tolerability, and preliminary immune-related characteristics and efficacy data, and choose 2-3 advanced solid tumors to enter the expansion phase (Stage Ib).
Timeline
- Start
- 2024-08-29
- Primary completion
- 2026-07
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | InnoPCV | Messenger RNA (mRNA) | 0.06 mg | Intramuscular |
| Subject | InnoPCV | Messenger RNA (mRNA) | 1 mg | Intramuscular |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |