To evaluate the safety and tolerability of combined administration of VSV injection solutions carrying different targets via multiple routes for treating advanced malignant solid tumors.
This is an open-label, dose-escalation phase I clinical trial designed to evaluate the safety and tolerability of combined administration of vesicular stomatitis virus (VSV) injection solutions carrying different targets via multiple routes in patients with advanced malignant solid tumors, and to preliminarily explore the maximum tolerated dose (MTD), recommended phase II dose (RP2D), as well as the preliminary anti-tumor activity and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of this regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Administer twice every two weeks.
Cancer Hospital Chinese Academy of Medical Scienc
Langfang, Hebei, China
RECRUITINGIncidence of Dose-Limiting Toxicities (DLTs)
Incidence and characteristics of DLTs graded according to NCI CTCAE v5.0. The DLT observation period is 21 days post-administration.
Time frame: Within 21 days after administration
Incidence of Adverse Events (AEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.
Time frame: From signing ICF until 24 months after the last infusion.
Objective Response Rate (ORR)
Overall response rate assessed per RECIST 1.1
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression,up to 24 months.
Duration of Response (DOR)
The time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death from any cause.
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression,up to 24 months.
Progression-Free Survival (PFS)
The time from the first dose of study drug until the first documentation of objective tumor progression or death from any cause.
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression,up to 24 months.
Overall Survival (OS)
The time from the first dose of study drug to death from any cause.
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Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression,up to 24 months.
Biodistribution and Viral Shedding of VSV
Measurement of VSV viral load/concentration in blood, urine, saliva, feces, and at the injection site to evaluate viral distribution and clearance.
Time frame: Starting before the first dose and continuing until 28 days (±7 days) after the last dose
Changes in Peripheral Blood Cytokine Levels
Assessment of cytokine levels following VSV injection.
Time frame: Starting before the first dose and continuing until 28 days (±7 days) after the last dose
Changes in C-reactive Protein (CRP) Levels
Assessment of systemic inflammatory response by measuring serum CRP levels.
Time frame: Starting before the first dose and continuing until 28 days (±7 days) after the last dose
Changes in Peripheral Lymphocyte Subsets
Assessment of the proportions and/or absolute counts of T cells, B cells, and NK cells in peripheral blood.
Time frame: Starting before the first dose and continuing until 28 days (±7 days) after the last dose