Platform Study of VSV-Based Recombinant Oncolytic Viruses for the Treatment of Advanced Malignant Tumors

A Phase I Platform Study of VSV-Based Recombinant Oncolytic Viruses for the Treatment of Advanced Malignant Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Biological: VSV injection

Detailed Description

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
• Enrollment (Estimated): 27
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yanjie Han, MD; Phone Number: +86010-87788165; Email: annyhan_1997@163.com
• Study Contact Backup: Name: Shuhang Wang, MD; Phone Number: 13581809307; Email: wangshuhang@cicams.ac.cn

Study Locations

• China
  • Hebei
    • Langfang, Hebei, China
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Scienc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily sign the informed consent form, understand this study, and agree to comply with the protocol and complete all trial procedures
2. Be at least 18 years of age at the time of signing the ICF, with no gender restrictions.
3. Patients with advanced solid tumors confirmed by histopathological/cytological examination of primary and/or metastatic lesions.
4. Patients who have failed standard therapy, lack a standard last-line treatment option, or are medically ineligible for standard therapy.
5. Subjects with an ECOG performance status of 0-2 and an estimated survival of ≥12 weeks.
6. Adequate organ and hematopoietic function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/LPlatelet count ≥ 75 × 10⁹/L (no platelet transfusion or thrombopoietin (TPO) therapy within 2 weeks prior to first dose)Hemoglobin ≥ 90 g/L (no blood transfusion within 2 weeks)Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CCr) ≥ 50 mL/min Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN for patients with liver metastases, AST and ALT < 5 × ULN， Serum total bilirubin (TBIL) ≤ 2 × ULN， International Normalized Ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
7. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.
8. Male and female subjects of reproductive potential must agree to use reliable contraception during the trial and for at least 6 months after the last dose. Translated with DeepL.com (free version)

Exclusion Criteria:

1. Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, and subjects with malignancies within the scope of the indication.
2. Lesions intended for injection with a maximum diameter >100 mm；
3. Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks；
4. Subjects scheduled for or who have previously undergone tissue/organ transplantation；
5. Subjects with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count < 350 cells/uL Patients with positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at screening, with HBV-DNA above the lower limit of detection patients with positive HCV antibody at screening and HCV-RNA above the lower limit of detection subjects with positive syphilis serology
6. Subjects requiring antiviral medication during the study period or within 5 half-lives of antiviral medication at the time of first dosing.
7. Subjects requiring therapeutic anticoagulant medication during the study period.
8. Subjects with uncontrolled active infection of ≥Grade 3 severity according to CTCAE v5.0 that is clinically significant
9. Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose Received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer) Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to first dose Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to first dose Received nitrosourea or mitomycin C within 6 weeks prior to first dose Palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to first dose)
10. Uncontrolled hypertension, pulmonary hypertension, or unstable angina myocardial infarction, coronary artery bypass grafting, or stenting within 6 months prior to dosing history of chronic heart failure at New York Heart Association (NYHA) functional class III-IV Severe arrhythmias requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia deemed by the investigator to have no impact on the trial), including QTcF ≥ 450 ms in males or ≥ 470 ms in females (calculated using Fridericia's formula) cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VM7V02; VM7V02： 1 mL/vial, 6.0E10 PFU/mL，Administer twice every two weeks.	Biological: VSV injection; Administer twice every two weeks.
Experimental: VM8V02; VM8V02：1 mL/vial, 6.0E10 PFU/mL，Administer twice every two weeks.	Biological: VSV injection; Administer twice every two weeks.
Experimental: VM8V01; VM8V01： 1 mL/vial, 6.0E10 PFU/mL，Administer twice every two weeks.	Biological: VSV injection; Administer twice every two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)	Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.	From signing ICF until 24 months after the last infusion.
Incidence 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.	Within 21 days after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.
Objective Response Rate (ORR)	Overall response rate assessed per RECIST 1.1	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.	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.	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.	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.	Starting before the first dose and continuing until 28 days (±7 days) after the last dose

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Study Director: Shuhang Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: immunotherapy; oncolytic virus
• Other Study ID Numbers: VSV-A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No