drugset / Trial / NCT07594964

To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors

NCT07594964 ↗

Phase 1 Recruiting 48 enrolled Shenzhen Xinhe Biomedical
NaSingle-groupOpen-labelTreatment

Summary

The goal of this interventional clinical study is to learn the safety and preliminary efficacy of XH001 injection (Personalized mRNA tumor neoantigen vaccine) combined with standard adjuvant treatment in treating patients with high-risk recurrent solid tumors after radical surgery. The main questions it aims to answer are: What medical problems do participants have when using the combined treatment? Does XH001 injection combined with standard adjuvant treatment induce a specific T-cell response, and can it prolong the patient's relapse-free survival?

Timeline

Start
2025-08-25
Primary completion
2029-10-30
Completion
2030-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject XH001 Vaccine — —
Background Calcium folinate Unknown — —
Background Oxaliplatin Small molecule — —
Background fluorouracil Small molecule — —
Background lrinotecan Unknown — —