At a glance
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The Application of Novel Oncolytic Virus in Late Stage Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Oncolytic Virus SDJ001 and Oncolytic Virus YD06-1 for Malignant Tumor. Targeting 24 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of novel oncolytic virus in late stage solid tumors.
Study Details
Timeline
Interventions
Patients in the study receive intratumoral treatment with SDJ001 at two dose levels: 5x10\^11 and 1x10\^12 pfu per person. At the current dose levels, intratumoral injection is administered on the first day of each treatment cycle. Each treatment cycle consists of three weeks, continuing until tumor growth is observed following injection or until the patient experiences intolerable toxic effects. Ultrasound-guided injection may be used when necessary (2.0 mL for tumors with a diameter \>2.5 cm, 1.0 mL for diameters of 1.5-2.5 cm, 0.5 mL for diameters of 0.5-1.5 cm, and 0.1 mL for diameters \<0.5 cm, with a maximum of 4 mL).
Patients in the study receive intratumoral treatment with a novel oncolytic virus YD06-1 at a concentration of 10\^6 pfu/mL to 10\^8 pfu/ml following a dose escalation plan. Each subject receives only one injection at the corresponding concentration, with the dose determined based on the size of the tumor mass. (Diameter ≤1.5 cm, maximum of 1 mL; diameter 1.5-2.5 cm, maximum of 2 mL; diameter greater than 2.5 cm, maximum of 4 mL). The second dose is administered three weeks after the first dose, followed by subsequent doses at two-week intervals.