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.
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.
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.
Sequential
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors
Biological/VaccineThe maximum number of lesions that each participant is allowed to inject at one time is two.
Evaluate the safety and tolerability of GC001
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs)，treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Maximal tolerable dose
During the DLT observation period, the number of cases with DLT is less than or equal to the maximum dose of 1/6 of the total number of cases, and six evaluable participants are required to determine MTD.
Anti-tumor activity of GC001: overall response rate (ORR).
To evaluate the overall response rate (ORR) as a measurement of tumor response and disease progression.
Anti-tumor activity of GC001: duration of response (DOR).
To evaluate the duration of response (DOR) as a measurement of tumor response and disease progression.
Anti-tumor activity of GC001:progression-free survival (PFS).
To evaluate the progression-free survival (PFS) as a measurement of tumor response and disease progression.
Evaluate the viral biological distribution and shedding of GC001
Viral biodistribution and shedding analysis for GC001 injection are performed based on the viral Biodistribution and shedding Analysis Set (BVSS). Biological collection samples include blood, urine, throat swabs, injection site and injection site dressing samples (for tumor injection at the percutaneous puncture site only),and determination of viral DNA copy number in the above samples.
Pharmacodynamic analysis of immune cells in the peripheral blood
The lymphocyte ratio of CD3 + / CD4 + , CD3 + / CD8 + and the ratio of CD4 + / CD8 + are measured in the peripheral blood .
Pharmacodynamic analysis of cytokine levels in the peripheral blood.
To assess the levels of cytokines including IFN-γ, TNF-α, IL-5 and IL-6 in the peripheral blood.
immunogenicity
Immunogenicity analysis will measure the concertation of antidody (anti-VV antibody (ADA) and neutralizing antibody (Nab) )in the peripheral blood.
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