A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors
NCT Number: NCT06508307
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Sarcoma|Cervical Cancer|Colon Cancer|Lung Cancer|Ovarian Cancer|Pancreatic Cancer|Hepatocellular Carcinoma|Breast Cancer|Gastric Cancer
Interventions: BIOLOGICAL: A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors
Sponsor: GONGCHU Biotechnology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-26
Completion Date: 2025-06
Locations: Henan Cancer Hospital, Zhengzhou, Henan, 450000, China

Summary:
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.

Primary Outcome Measures: 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., DLT Observation Period，Up to 28 days from GC001 injection|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., DLT Observation Period,Up to 28 days from GC001 injection
Secondary Outcome Measures: 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., Up to 2 years|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., Up to 2 years from GC001 injection|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., Up to 2 years from GC001 injection|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., Up to 2 years from GC001 injection
Other Outcome Measures: 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 ., Up to 2 years from GC001 injection|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., Up to 2 years from GC001 injection|immunogenicity, Immunogenicity analysis will measure the concertation of antidody (anti-VV antibody (ADA) and neutralizing antibody (Nab) )in the peripheral blood., Up to 2 years from GC001 injection