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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
WGc-043 Injection, intramuscular injection
Dose limiting toxicity (DLT)
Time frame: During one year after initial treatment
Safety: Type, frequency, and severity of treatment-related adverse events as assessed by CTCAE V5.0
Time frame: During one year after initial treatment
MTD/RP2D
Time frame: During one year after initial treatment
Preliminary antitumor activity: Objective response rate (ORR)
Time frame: During one year after initial treatment
Preliminary antitumor activity: Disease control rate (DCR)
Time frame: During one year after initial treatment
Preliminary antitumor activity: Duration of response (DoR)
Time frame: During one year after initial treatment
Preliminary antitumor activity: Progression-free survival (PFS)
Time frame: During one year after initial treatment
Preliminary antitumor activity: 1-year survival rate
Time frame: During one year after initial treatment
Immunogenicity: The level of antigen-specific T cells
Time frame: During one year after initial treatment
Pharmacokinetics (PK) characteristics: Maximum Plasma Concentration [Cmax] of mRNA
Time frame: During one year after initial treatment
Pharmacokinetics (PK) characteristics: Maximum Plasma Concentration [Cmax] of cationic lipids
Time frame: During one year after initial treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.