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

June 14, 2026 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: From signing ICF until 24 months after the last infusion.
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)
Time Frame: Within 21 days after administration
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
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.
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)
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.
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)
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.
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)
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 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
Time Frame: Starting before the first dose and continuing until 28 days (±7 days) after the last dose
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
Time Frame: Starting before the first dose and continuing until 28 days (±7 days) after the last dose
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
Time Frame: Starting before the first dose and continuing until 28 days (±7 days) after the last dose
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
Time Frame: Starting before the first dose and continuing until 28 days (±7 days) after the last dose
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shuhang Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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