NCT07348042

Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors

An Open, Multi-center Phase I Clinical Study Evaluating the Safety, Tolerance, Pharmacokinetics and Immunogenicity of RGL-270 Single Drug and Combined With Adebelimab in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Xian-Jun Yu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DRUG	RGL-270 Injection	Repeated medication, increase the dose
DRUG	Adebelimab Injection	Repeated medication, the dose is maintained

Timeline

• Start date: 2025-09-07
• Primary completion: 2027-03-31
• Completion: 2027-12-31
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China