Advanced Solid TumorPhase 1NCT07656116
Platform Study of VSV-Based Recombinant Oncolytic Viruses for the Treatment of Advanced Malignant Tumors
A Phase 1 study testing VSV injection in people with Advanced Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- VSV injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2026to 31 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form, understand this study, and agree to comply with the protocol and complete all trial procedures
- Be at least 18 years of age at the time of signing the ICF, with no gender restrictions.
- Patients with advanced solid tumors confirmed by histopathological/cytological examination of primary and/or metastatic lesions.
- Patients who have failed standard therapy, lack a standard last-line treatment option, or are medically ineligible for standard therapy.
- Subjects with an ECOG performance status of 0-2 and an estimated survival of ≥12 weeks.
- 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
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.
- 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)
Who cannot join
- 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.
- Lesions intended for injection with a maximum diameter >100 mm；
- Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks；
- Subjects scheduled for or who have previously undergone tissue/organ transplantation；
- 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
- Subjects requiring antiviral medication during the study period or within 5 half-lives of antiviral medication at the time of first dosing.
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- Subjects requiring therapeutic anticoagulant medication during the study period.
- Subjects with uncontrolled active infection of ≥Grade 3 severity according to CTCAE v5.0 that is clinically significant
- 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)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Scienc
Langfang, Hebei
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- VSV injection
- Keywords
- oncolytic virus, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSV injectionBiological
Administer twice every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| VM7V02 | Experimental | VM7V02： 1 mL/vial, 6.0E10 PFU/mL，Administer twice every two weeks. Receives: Biological: VSV injection |
| VM8V02 | Experimental | VM8V02：1 mL/vial, 6.0E10 PFU/mL，Administer twice every two weeks. Receives: Biological: VSV injection |
| VM8V01 | Experimental | VM8V01： 1 mL/vial, 6.0E10 PFU/mL，Administer twice every two weeks. Receives: Biological: VSV injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From signing ICF until 24 months after the last infusion.
Secondary outcomes (8)
Objective Response Rate (ORR)
Overall response rate assessed per RECIST 1.1
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Starting before the first dose and continuing until 28 days (±7 days) after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start29 Jan 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhang Wang, Study director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656116
- Sponsor's protocol ID
- VSV-A01
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Platform Study of VSV-Based Recombinant Oncolytic Viruses for the Treatment of Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT07656116
- Acronym / sponsor ID
- VSV-A01
- Conditions
- Advanced Solid Tumor
- Keywords
- oncolytic virus, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VM7V02 | Experimental | Biological: VSV injectionVM7V02： 1 mL/vial, 6.0E10 PFU/mL，Administer twice every two weeks. |
| VM8V02 | Experimental | Biological: VSV injectionVM8V02：1 mL/vial, 6.0E10 PFU/mL，Administer twice every two weeks. |
| VM8V01 | Experimental | Biological: VSV injectionVM8V01： 1 mL/vial, 6.0E10 PFU/mL，Administer twice every two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily sign the informed consent form, understand this study, and agree to comply with the protocol and complete all trial procedures
- Be at least 18 years of age at the time of signing the ICF, with no gender restrictions.
- Patients with advanced solid tumors confirmed by histopathological/cytological examination of primary and/or metastatic lesions.
- Patients who have failed standard therapy, lack a standard last-line treatment option, or are medically ineligible for standard therapy.
- Subjects with an ECOG performance status of 0-2 and an estimated survival of ≥12 weeks.
Key exclusion criteria (10 listed)
- 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.
- Lesions intended for injection with a maximum diameter >100 mm；
- Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks；
- Subjects scheduled for or who have previously undergone tissue/organ transplantation；
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSV injectionAdminister twice every two weeks. | Biological | VM7V02, VM8V01, VM8V02 |
Primary outcome
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.
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.
8 secondary outcomes
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.
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.
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.
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.
Biodistribution and Viral Shedding of VSV
Time frame: 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
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
Changes in Peripheral Lymphocyte Subsets
Time frame: Starting before the first dose and continuing until 28 days (±7 days) after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuhang Wang study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VSV injection in people with Advanced Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanjie Han, MD (+86010-87788165, annyhan_1997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Within 21 days after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.