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

Inclusion criteria

• Male or female patients aged ≥18 years at the time of screening;
• Histologically or cytologically confirmed locally recurrent or metastatic EBV-positive solid tumors that are not amenable to curative treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Estimated life expectancy of ≥3 months;
• At least one measurable lesion; previously irradiated lesions cannot be considered as target lesions unless there is evidence of significant progression;
• Adequate major organ function, with organ function parameters meeting the criteria specified in the protocol;
• 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;
• Ability to understand and voluntarily sign the written informed consent form prior to participation in the trial;
• Ability to communicate effectively with the investigator and comply with the protocol requirements throughout the trial.

Exclusion criteria

• 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.
• 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.
• 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.
• Any active autoimmune disease or a history of autoimmune disease.
• 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.