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NCT07028047

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

Not yet recruiting Phase 1 Last updated 19 June 2025
What this trial tests

Phase 1 trial testing WGc-043 Injection in Advanced EBV-positive Malignant Solid Tumors in 64 participants. Not yet recruiting.

Timeline
23 June 2025
Primary endpoint
30 June 2027
30 June 2028

Quick facts

Lead sponsorSun Yat-sen University
PhasePhase 1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment64
Start date23 June 2025
Primary completion30 June 2027
Estimated completion30 June 2028

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-sen University

Who can join

18 and older, any sex, with Advanced EBV-positive Malignant Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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