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Evaluation of WGc-043 Injection in Advanced Solid Tumors: Phase I Study
Sponsor: Sun Yat-sen University
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
WGc-043 Injection
WGc-043 Injection, intramuscular injection