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

NCT07182435 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Solid Tumor Malignancies

Interventions

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.

Sponsors & Collaborators

  • Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

    lead OTHER

Principal Investigators

  • Binghe Xu · Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  • Jianhua Chang · Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07182435 on ClinicalTrials.gov