NCT07182435

Exploratory Clinical Study of Personalized mRNA Tumor Vaccine RH125 in Patients With Advanced Solid Tumors

A Phase 1 Clinical Trial of Personalized mRNA Tumor Vaccine RH125 in Patients With Advanced or Metastatic Solid Tumors Evaluating the Safety, Tolerability, and Efficacy

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 clinical study investigating RH125 as monotherapy or in combination therapy in patients with locally advanced or metastatic solid tumors who failed standard treatment, or were intolerant to standard treatment, or declined standard treatment. The aim of the study is to evaluate the tolerability, safety, immunogenicity, and preliminary efficacy of RH125 monotherapy or combination with PD-1 blocker.

Detailed description

This study will be divided into monotherapy dose escalation and combination therapy dose escalation phases. Each phase requires the enrollment of 12-18 subjects, with a total of 24-36 subjects to be enrolled in the entire study. Both the monotherapy dose escalation and combination therapy dose escalation will involve 3 dose levels, which are 100 μg, 150 μg, and 200 μg respectively. A "3+3" design will be adopted, and the Dose-Limiting Toxicity (DLT) observation period will be 21 days for both phases.

Conditions

• Solid Tumor Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	personalized neoantigen mRNA tumor vaccine	RH125 is a personalized neoantigen mRNA tumor vaccine which is constructed based on the results of patients' neoantigen sequencing.

Timeline

• Start date: 2025-09-15
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: China