The Application of Novel Oncolytic Virus in Late Stage Solid Tumors

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 15, 2023

Primary Completion Date

October 15, 2024

Study Completion Date

October 15, 2025

Conditions
Malignant Tumor
Interventions
DRUG

Oncolytic Virus SDJ001

"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)."

DRUG

Oncolytic Virus YD06-1

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.

Trial Locations (1)

610041

RECRUITING

West China Hospital, Sichuan University, Chengdu

All Listed Sponsors
lead

West China Hospital

OTHER