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NOT YET RECRUITING
NCT07028047
PHASE1

Evaluation of WGc-043 Injection in Advanced Solid Tumors: Phase I Study

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Epstein-Barr virus (EBV) is an important tumor-associated virus. In 1997, the World Health Organization (WHO) officially classified EBV as a Group 1 carcinogen, as it is implicated in the pathogenesis of various epithelial malignancies and multiple types of lymphomas. Epithelial malignancies associated with EBV infection include nasopharyngeal carcinoma, gastric cancer, colorectal cancer, breast cancer, cervical cancer, prostate cancer, and oral cancer, among others. Currently, optimal therapeutic strategies for EBV-associated solid tumors remain lacking, particularly in patients with recurrent, metastatic, or refractory disease. Furthermore, although EBV infection plays a significant role in the development and progression of EBV-positive tumors and may influence patient prognosis, there are currently no precision therapeutic approaches specifically targeting EBV-positive lymphomas. Thus, treatment options for this patient population warrant further attention. WGc-043 injection is a therapeutic tumor vaccine based on messenger RNA (mRNA) targeting tumor-specific antigens expressed in EBV-positive tumors. This Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of WGc-043 in patients with advanced EBV-positive malignant solid tumors, thereby providing a scientific basis for subsequent clinical development.

Official title: Evaluation for Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Anti-tumor Activity of WGc-043 Injection in Patients With Advanced Malignant Solid Tumors: Phase I Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2025-06-23

Completion Date

2028-06-30

Last Updated

2025-06-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

WGc-043 Injection

WGc-043 Injection, intramuscular injection