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RECRUITING
NCT07697937
PHASE2

YH02 Injection for Intra-tumor Injection Therapy in Advanced Solid Tumors With Unresponsive or Failure-Treated Cases

Sponsor: Tianjin First Central Hospital

View on ClinicalTrials.gov

Summary

The preclinical pharmacological mechanism of YH02 injection is well established. By constructing a vector expressing MMP13, introducing a human S promoter, and genetically modifying the capsid protein, the virus's permeability, tumor targeting capability, and infection efficiency were significantly enhanced. Preclinical pharmacodynamic studies demonstrated that YH02 exhibits potent tumor growth inhibitory effects in various human-and murine-derived solid tumor models (including breast cancer, liver cancer, and melanoma). Given that oncolytic virus therapies already have approved products with demonstrated safety and efficacy worldwide, this study may offer potential clinical benefits for patients with advanced solid tumors who have failed standard treatments. YH02 injection has undergone an open-label, dose-escalating, and expanded Phase I clinical study in China aimed at evaluating the safety, tolerability, biodistribution characteristics, viral clearance, and immunogenicity of intratumoral administration of YH02 injection in patients with advanced solid tumors who have failed adequate standard therapy and lack effective treatment options, while preliminarily investigating its efficacy. No high-grade adverse drug reactions (ADRs) have been observed to date, nor were there any serious adverse events (SAEs), severe adverse drug reactions (SUSARs), or fatal events. The clinical safety and tolerability of this product for intratumoral administration are favorable.

Official title: Clinical Study of YH02 Injection for Intra-tumor Injection Therapy in Advanced Solid Tumors With Unresponsive or Failure-Treated Cases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-06-23

Completion Date

2028-07-31

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

DRUG

YH-02

The preclinical pharmacological mechanism of YH02 injection is well established. By constructing a vector expressing MMP13, introducing a human S promoter, and performing genetic modifications to the capsid protein, the drug significantly enhances viral permeability, tumor targeting capability, and infection efficiency.

Locations (1)

Tianjin First Central Hospital

Tianjin, China