OncoMatch/Clinical Trials/NCT06508307
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors
Is NCT06508307 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies A Phase I Clinical Study of Intratumoral for sarcoma.
Treatment: A Phase I Clinical Study of Intratumoral — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Cervical Cancer
Colorectal Cancer
Non-Small Cell Lung Carcinoma
Ovarian Cancer
Pancreatic Cancer
Hepatocellular Carcinoma
Breast Carcinoma
Gastric Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antitumor therapy
Exception: palliative radiotherapy allowed
antitumor therapy, including radiation therapy (except palliative radiotherapy), chemotherapy, biotherapy, endocrine therapy, and immunotherapy within 28 days prior to the first administration of the drug
Cannot have received: small molecule targeted agents with antitumor effects
Individuals using small molecule targeted agents with antitumor effects within 14 days prior to the first administration of the drug or within 5 times the half-life of the drug (whichever is longer)
Cannot have received: herbal medicines with antitumor effects
Individuals using herbal medicines with antitumor effects within 14 days prior to the first administration of the drug
Cannot have received: lysosomal virus, stem cell, or gene therapy products
Patients who have previously received lysosomal virus, stem cell, or gene therapy products
Lab requirements
Blood counts
platelets (PLT) ≥ 80 × 10^9/L, neutrophil count (ANC) ≥ 1.5 × 10^9/L, and hemoglobin ≥ 9 g/dL (without adjuvants like EPO, G-CSF, or GM-CSF in the 14 days leading up to the first dose, and not having received a blood transfusion for at least 7 days)
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
Liver function
total bilirubin ≤ 1.5 × ULN (patients with Gilbert syndrome may be enrolled with a total bilirubin ≤ 3 × ULN), AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN in the presence of hepatic metastases)
Cardiac function
QT interval (QTcF) ≤ 470 ms in female and ≤ 450 ms in male
organ function and bone marrow reserve: Hematology: platelets (PLT) ≥ 80 × 10^9/L, neutrophil count (ANC) ≥ 1.5 × 10^9/L, and hemoglobin ≥ 9 g/dL (without having received adjuvants like EPO, G-CSF, or GM-CSF in the 14 days leading up to the first dose, and not having received a blood transfusion for at least 7 days); Coagulation function: INR ≤ 1.2, APTT ≤ 1.2 × ULN, PT ≤ 1.2 × ULN; Hepatic function: total bilirubin ≤ 1.5 × ULN (patients with Gilbert syndrome may be enrolled with a total bilirubin ≤ 3 × ULN), AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN in the presence of hepatic metastases); Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula); Cardiac function: QT interval (QTcF) ≤ 470 ms in female and ≤ 450 ms in male.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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