CI

At a glance

ClinicalIndex Comparison Record
Phase 1Unknown· 24 target
Drug / intervention
Oncolytic Virus SDJ001 +1 moredrug
Likely dose
Oncolytic Virus SDJ001 2.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06080984
NCT06080984Phase 1Unknown

The Application of Novel Oncolytic Virus in Late Stage Solid Tumors

West China Hospital·interventional·Posted Oct 12, 2023·Updated Oct 12, 2023

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Tumor
CountriesChina
Collaborators--

Timeline

Phase 1UnknownOverdue
202420252026
First PostedOct 12, 2023
Enrollment StartOct 15, 2023
Primary CompletionOct 15, 2024
Study CompletionOct 15, 2025
TodayJul 1, 2026
Enrollment to primary: 1 yearPosted 2.7 years ago

Interventions

Oncolytic Virus SDJ001drug

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).

Oncolytic Virus YD06-1drug

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.