drugset / Trial / NCT05264974
Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization
NaSequentialOpen-labelTreatment
Summary
The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.
Timeline
- Start
- 2026-03-17
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous total tumor mRNA loaded DOTAP liposome vaccine | Messenger RNA (mRNA) | 0.00015625 mg/kg | Intravenous |
| Subject | Autologous total tumor mRNA loaded DOTAP liposome vaccine | Messenger RNA (mRNA) | 0.0003125 mg/kg | Intravenous |
| Subject | Autologous total tumor mRNA loaded DOTAP liposome vaccine | Messenger RNA (mRNA) | 0.000625 mg/kg | Intravenous |
| Subject | Autologous total tumor mRNA loaded DOTAP liposome vaccine | Messenger RNA (mRNA) | 0.00125 mg/kg | Intravenous |
| Subject | Autologous total tumor mRNA loaded DOTAP liposome vaccine | Messenger RNA (mRNA) | 0.0025 mg/kg | Intravenous |