drugset / Trial / NCT06888648
Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.
Phase 1/2
Not yet recruiting
30 enrolled
Zhejiang University
Hangzhou Neoantigen Therapeutics Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a single-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.
Timeline
- Start
- 2025-04-01
- Primary completion
- 2027-04-01
- Completion
- 2028-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | iNeo-Vac-R01 | Messenger RNA (mRNA) | 100 ug | — |
| Background | Irinotecan | Small molecule | 135 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 68 mg/m2 | Intravenous |
| Background | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |