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The Application of Novel Oncolytic Virus in Late Stage Solid Tumors

NCT06080984 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-10-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of novel oncolytic virus in late stage solid tumors.

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xingchen Peng · West China Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2024-10-15
Completion
2025-10-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06080984 on ClinicalTrials.gov