drugset / Trial / NCT07676890
A Single-Arm, Open-Label, Prospective Study Evaluating the Safety, Tolerability, and Immunogenicity of the NeoOVIV Vaccine in Patients With Ovarian Cancer After Surgery
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I, single-arm, open-label, dose-escalation study in patients with stage II or III ovarian cancer after surgery. The study will evaluate the safety, tolerability, immune response, and preliminary clinical activity of NeoOVIV, a personalized mRNA-lipid nanoparticle vaccine, when given with standard adjuvant chemotherapy and a PD-1 antibody.
Timeline
- Start
- 2026-07-31
- Primary completion
- 2028-05-30
- Completion
- 2028-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NeoOVIV | Messenger RNA (mRNA) | 25 ug | Intramuscular |
| Subject | NeoOVIV | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | NeoOVIV | Messenger RNA (mRNA) | 100 ug | Intramuscular |