Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High
This study is a phase I clinical trial of multi-center, open label, dose increase and dose expansion. It aims to evaluate the safety, tolerance, PK characteristics, immunogenicity and initial efficacy of personalized new antigen mRNA vaccine RGL-270 (hereinafter referred to as RGL-270) alone and combined with adebelizu
| Condition(s) | Tumor, Solid |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This study is a phase I clinical trial of multi-center, open label, dose increase and dose expansion. It aims to evaluate the safety, tolerance, PK characteristics, immunogenicity and initial efficacy of personalized new antigen mRNA vaccine RGL-270 (hereinafter referred to as RGL-270) alone and combined with adebelizumab in patients with high risk of recurrence of malignant solid tumors after radical treatment. |
| Who can participate | Inclusion Criteria: Pre-screening period 1. Subjects should understand and abide by the relevant research procedures, and voluntarily sign the prior informed consent form; 2. Age 18-75 years old (including boundary value), gender is not limited; 3. For malignant solid tumors confirmed by histology or cytology after radical resection, the subjects are allowed to complete standard adjuvant treatment, or no standard adjuvant treatment, or adjuvant treatment intolerance before receiving the first administration of this study: 4. Willing to provide sufficient tumor tissue specimens and peripheral blood for genetic testing and new antigen analysis; 5. Fertile female subjects and male subjects whose partners are women of childbearing age must agree to comply with the contraceptive requirements fo |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Xian-Jun Yu |
| Locations | Shanghai, China |
| Start date | 2025-09-07 |
| NCT ID | NCT07348042 |
| Official listing | https://clinicaltrials.gov/study/NCT07348042 |