The purpose of this study is to evaluate the safety and primary efficacy of the combination therapy of recombinant human IL-21-expressing oncolytic vaccinia virus (hV01) and the PD-1 Inhibitor Tislelizumab in patients with advanced solid tumors.
Signing an informed consent form.
Men or women aged 18 to 75 years.
Histologically and/or cytologically confirmed advanced solid tumors refractory or failed to respond to standard therapies.
At least one measurable lesion according to RECIST v1.1 criteria, which is suitable for intratumoral injection of hV01 either directly or with the assistance of B-ultrasound, or CT scan. The baseline longest diameter of the lesion targeted for injection should be more than 1.5 cm.
Receiving any of the following anti-tumor treatments within a specified time period: (1) Systemic anti-tumor treatment, including chemotherapy, large-molecule targeted therapy, immunotherapy, and endocrine therapy within 4 weeks before first dose of hV01 (within 6 weeks of dosing for nitrosourea or mitomycin C); (2) Small-molecule targeted therapy within 2 weeks before first dose of hV01 or within five half-lives of the small-molecule targeted drug (whichever is longer); (3)Radiotherapy (excluding palliative radiotherapy) within 2 weeks before first dose of hV01. (4) previous treatment with an oncolytic virus.
Receiving any investigational drugs for clinical trials within 4 weeks prior to the first dose of hV01.
Patients with clinical symptoms of central nervous system (CNS) metastasis or meningeal metastasis, or other evidence indicating that CNS or meningeal metastases are not controlled.
Known or suspected active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and Hashimoto's thyroiditis).
Single group
recombinant human IL-21-expressing oncolytic vaccinia virus injection
Biological/VaccinehV01 is a recombinant vaccinia virus with deletions of the viral thymidine kinase (TK) and viral growth factor (VGF) genes and insertion of the human IL-21 gene.
Dose-limiting toxicities
To observe dose-limiting toxicities (DLTs) after hV01 administration as a single agent, or combined with Tislelizumab.
Adverse events
Assess the frequency, severity, and nature of adverse events (AEs).
Overall Response Rate (ORR)
The proportion of patients who have a partial or complete response to therapy.
Disease Control Rate (DCR)
The percentage of participants who gain a complete response, a partial response, or stable disease.
Duration of Response (DOR)
The time from administration of the first dose of hV01 to disease progression or death in patients who achieve a complete or partial response.
Progression-Free Survival (PFS)
The time from administration of the first dose of hV01 to disease progression or death from any cause.
Click on the lead sponsor to view all of their trials.
Hangzhou Converd Co., Ltd.
Lead sponsor
Xiamen Humanity Hospital
Collaborator
