NCT06508307
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors
Recruiting · Phase 1 · GONGCHU Biotechnology Co., Ltd · registry updated 2025-08-21
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The present trial is an open, single-arm phase I clinical study aimed at assessing the safety, tolerability, viral distribution and shedding patterns, pharmacodynamics, immunogenicity, and antitumor efficacy of GC001 oncolytic virus injection in patients with advanced solid tumors following a single administration.
Inclusion
- To be eligible for participation in this study, individuals must meet the following criteria:
- Fully comprehend the purpose, nature, methods, and potential adverse effects of the trial, volunteer as a participant, and provide informed consent by signing the form prior to undergoing any procedures.
- Be male or female patients aged 18 to 75 years (including those with borderline age values).
- Patients with advanced solid tumors, including but not limited to: colorectal cancer, lung cancer, ovarian cancer, cervical cancer, etc., that have been histologically or cytologically diagnosed and for which there is either no current standard of care or the standard treatment has proven ineffective (progression of the disease after treatment or intolerance of treatment).
- Possess at least one extracranial measurable lesion (as determined by a CT scan or MRI conducted no more than 4 weeks before signing the informed consent form) that is suitable for intratumoral injection based on RECIST v1.1 criteria.
- Have an Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1.
Exclusion
- Patients with a previous diagnosis of any other malignancy within 5 years prior to the first dose, except for malignancies with a low risk of metastasis and risk of death (5-year survival \> 90%), such as adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, and other carcinomas in situ.
- Females of childbearing age who have a positive pregnancy test or are lactating.
- Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.
- Those who have received smallpox vaccination and experienced severe systemic reactions or side effects.
- Patients who have previously received lysosomal virus, stem cell, or gene therapy products.
- Individuals using other investigational drugs or participating in clinical trials of other drugs within 28 days prior to the first dose (except for those who did not receive the test drug).