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

Launched by SUN YAT-SEN UNIVERSITY · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called WGc-043 injection, which is a type of vaccine designed to help the body’s immune system target certain cancers linked to the Epstein-Barr virus (EBV). EBV is known to be involved in several types of difficult-to-treat cancers, including some that affect the nose, stomach, breast, and other organs. This early-phase study aims to find out if the treatment is safe, how the body handles it, and whether it can trigger an immune response or show signs of helping to control the cancer.

People who may be eligible to join are adults with advanced EBV-positive solid tumors that have returned, spread, or can’t be cured with current treatments. Participants need to be in relatively good health with a good performance status and have measurable cancer lesions. They must also agree to use effective birth control during and after the study if applicable. During the trial, participants will receive the WGc-043 injection and be closely monitored for side effects and any changes in their cancer. This study is not yet recruiting, but it hopes to provide important information for developing better treatments for EBV-related cancers in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients aged ≥18 years at the time of screening;
• • 2. Histologically or cytologically confirmed locally recurrent or metastatic EBV-positive solid tumors that are not amenable to curative treatment;
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• • 4. Estimated life expectancy of ≥3 months;
• • 5. At least one measurable lesion; previously irradiated lesions cannot be considered as target lesions unless there is evidence of significant progression;
• • 6. Adequate major organ function, with organ function parameters meeting the criteria specified in the protocol;
• • 7. Women of childbearing potential (WOCBP) or male subjects must have no plans for pregnancy during the study and must agree to use effective contraception (including one or more non-pharmacologic contraceptive methods or complete abstinence from heterosexual intercourse) or safety measures during the trial and for 6 months after discontinuation of treatment;
• • 8. Ability to understand and voluntarily sign the written informed consent form prior to participation in the trial;
• • 9. Ability to communicate effectively with the investigator and comply with the protocol requirements throughout the trial.
• Exclusion Criteria:
• • 1. Patients with a history of other malignancies, except for those with a history of skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, gastrointestinal mucosal carcinoma, or other malignancies deemed by the investigator to be eligible for inclusion, provided that these cancers have been cured and have not recurred within 5 years prior to screening.
• • 2. Patients with symptomatic central nervous system (CNS) metastases or leptomeningeal metastases, or those with evidence indicating that CNS or leptomeningeal metastases are not well-controlled, as judged by the investigator to be unsuitable for inclusion.
• • 3. Patients with known uncontrolled cardiac symptoms or diseases, such as: New York Heart Association (NYHA) Class II or higher heart failure, unstable angina, myocardial infarction within the past 6 months, or clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
• • 4. Any active autoimmune disease or a history of autoimmune disease.
• • 5. Any uncontrolled clinical condition or other major medical illness that, in the judgment of the investigator, may interfere with the ability to provide informed consent, confound the interpretation of trial results, pose a risk to the patient's participation in the trial, or otherwise affect the achievement of trial objectives-including, but not limited to, uncontrolled pleural effusion, pericardial effusion, or ascites as determined by the investigator.