Advanced Solid TumorPhase 1NCT05644509
Study on the Treatment of Advanced Malignant Solid Tumor With Revottack and PD-1 Inhibitor
A Phase 1 study testing Oncolytic Virus Injection（Revottack）+PD-1 in people with Advanced Solid Tumor, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
This is a one arm, open clinical pharmacological exploration study initiated by researchers to evaluate the safety and effectiveness of vesicular stomatitis oncolytic virus injection (Revottack) combined with PD-1 inhibitor in patients with 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?
- Oncolytic Virus Injection（Revottack）+PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Dec 2022to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- The age at the time of signing the informed consent is ≥ 18 years old, regardless of gender;
- Patients with advanced malignant solid tumor confirmed by histology or cytology; Failure in standard treatment (disease progression or intolerable treatment after treatment) and no effective treatment means, or no standard treatment scheme, or inability to obtain standard treatment due to objective conditions.
- According to RECIST 1.1, there is at least one assessable tumor focus with the longest diameter ≥ 10mm (if it is a malignant lymph node, the short diameter ≥ 15mm is required);
- ECOG physical strength score 0-2;
- Full organ function:
- Blood system (no blood transfusion or hematopoietic stimulator treatment within 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelet (PLT) ≥ 75 × 109/L Hemoglobin (Hb) ≥ 80g/L Lymphocyte absolute value (LYM) ≥ 0.8 × 109/L liver function Total bilirubin (TBIL) ≤ 1.5 × ULN Alanine aminotransferase (ALT) ≤ 3 × ULN (Patients with liver metastasis or liver cancer: ≤ 5 × ULN ) Aspartate aminotransferase (AST) ≤ 3 × ULN (Patients with liver metastasis or liver cancer: ≤ 5 × ULN) renal function Creatinine clearance rate (Ccr) > 50ml/min/1.73m2 (calculated according to Cockcroft Gault formula) Coagulation function test Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN
- Eligible patients (male and female) with fertility must agree to work in Revottack Use reliable contraceptive methods (hormone or barrier method or abstinence) within 6 months after injection; The blood pregnancy test of female patients of childbearing age must be negative within 7 days before enrollment;
- Subjects must give informed consent to the study before the study, and voluntarily sign a written informed consent form.
Who cannot join
- Patients with active CNS metastasis and/or carcinomatous meningitis are known or found during screening. However, the following subjects are allowed to be included in the group: ① Patients with asymptomatic brain metastasis (that is, patients without progressive central nervous system symptoms caused by brain metastasis do not need to use corticosteroids) can participate. ② Subjects who had been treated and had stable brain metastases for at least 2 months had no evidence of new or expanded brain metastases.
- He received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatments within 2 weeks before the first use of the study drug;
- Participated in other unlisted clinical studies within 4 weeks before the first use of the study drug;
- Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks before the first use of the study drug, or major elective surgery required during the study period.
- Patients who received systemic corticosteroids (prednisone>10mg/day or equivalent dose of the same drug) or other immunosuppressants within 14 days before the first use of the study drug; The following cases are excluded: local, eye, intra articular and intranasal corticosteroids are used for treatment; Short term use of corticosteroids for prevention and treatment;
- Have received other oncolytic virus treatment within 8 weeks before the first use of the study drug;
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- Any vaccine was inoculated within 7 days before the first use of the study drug;
- Antiviral drugs were used within 2 weeks before the first use of the study drug, and long-acting interferon was used within 4 weeks;
- The adverse reaction of previous anti-tumor treatment has not recovered to ≤ 1 level (except for the toxicity judged by the researcher as no safety risk, such as alopecia, hypothyroidism stabilized by hormone replacement therapy, etc.);
- Uncontrolled active infection exists, which may seriously affect the efficacy and safety evaluation as judged by the researcher;
- Have a history of immunodeficiency, including HIV antibody test positive;
- Active hepatitis B (HBsAg positive and HBV DNA>the lower detection limit of the research center), or hepatitis C virus infection (anti HCV positive or HCV RNA positive), or syphilis infection;
- Cardiovascular and cerebrovascular diseases shall conform to any of the following:
- Poor control of hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Cardiac function ≥ Grade 2 congestive heart failure (NYHA classification);
- Arrhythmias requiring clinical intervention (including QTc ≥ 450ms (male) and QTc ≥ 470ms (female));
- Serious arteriovenous thromboembolism events, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism;
- The third space effusion that cannot be controlled clinically is not suitable to be included in the group according to the judgment of the researcher;
- Patients with active or ever suffered from autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except patients with clinically stable autoimmune thyroiditis;
- Known alcohol or drug dependence;
- Mental disorders or poor compliance;
- Pregnant or lactating women;
- The investigator believes that the subject is not suitable to participate in this clinical study because of other serious systemic diseases or other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
Han Zhengxiang, MD, 18052268612, cnhzxyq@163.com
About this study
Official title: A Clinical Pharmacological Study of Intravenous Administration of Vesicular Stomatitis Oncolytic Virus Injection (Revottack）Combined PD-1 Inhibitor in Patients With Advanced Malignant Solid Tumor
This is a one arm, open clinical pharmacological exploration study initiated by researchers to evaluate the safety and effectiveness of vesicular stomatitis oncolytic virus injection (Revottack) combined with PD-1 inhibitor in patients with advanced malignant solid tumors.
The purpose of this study is to evaluate the safety, tolerability, anti-tumor activity, immunogenicity, immune response, pharmacokinetic (PK) characteristics and shedding characteristics of Revottack injection combined with PD-1 inhibitor in patients with advanced solid tumors.
Read the detailed description
This is a one arm, open clinical pharmacological exploration study initiated by researchers to evaluate the safety and effectiveness of vesicular stomatitis oncolytic virus injection (Revottack) combined with PD-1 inhibitor in patients with advanced malignant solid tumors.
This study is planned to enroll 6-10 patients with advanced solid tumors. Subjects will receive the administration of revottack and PD-1( Toripalimab)inhibitor at a given time.
The purpose of this study is to evaluate the safety, tolerability, anti-tumor activity, immunogenicity, immune response, pharmacokinetic (PK) characteristics and shedding characteristics of Revottack injection combined with PD-1 inhibitor in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- Oncolytic Virus Injection（Revottack）+PD-1
- Keywords
- Oncolytic Virus, Revottack, PD-1(Toripalimab), Intravenous Injection, immunotherapy, immune Checkpoint Inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncolytic Virus Injection（Revottack）+PD-1Biological
Intravenous injection of Revottack injection combined with PD-1(Toripalimab） inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Oncolytic Virus Injection（Revottack）+PD-1 | Experimental | In the first three cycles, the subjects were administered on the first day and the sixth day of each cycle respectively; At the beginning of the fourth cycle, the subjects were administered on the sixth day of each cycle, 14 days a cycle.
PD-1 inhibitor(Toripalimab) Intravenous infusion, once every 2 weeks from the 6th day. Receives: Biological: Oncolytic Virus Injection（Revottack）+PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Graded according to the NCI CTCAE version 5.0.
Measured: Up to 6 months
Objective response rate
Assess the proportion of patients who achieved complete or partial response
Measured: Up to 2 years
Disease control rate
Assess the proportion of patients who achieved complete or partial or stable response
Measured: Up to 2 years
The changes from baseline of lymphocyte counts
The changes from baseline of Peripheral blood lymphocyte subtypes counts
Measured: Up to 28 days
The concentration of antiviral antibody
The concentration of antiviral antibody of Revottack in blood
Measured: Up to 22 Weeks
The rate of subjects with viral shedding of Revottack
The rate of subjects with viral RNA in the secretion
Measured: Up to 22 Weeks
The Tmax of Viral RNA in blood
Time to peak viral RNA concentration
Measured: Up to 22 Weeks
The Cmax of Viral RNA in blood
The peak viral RNA concentration
Measured: Up to 22 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644509
- Sponsor's protocol ID
- LWY22078CXY
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacological Study of Intravenous Administration of Vesicular Stomatitis Oncolytic Virus Injection (Revottack）Combined PD-1 Inhibitor in Patients With Advanced Malignant Solid Tumor
- ClinicalTrials.gov ID
- NCT05644509
- Acronym / sponsor ID
- LWY22078CXY
- Conditions
- Advanced Solid Tumor
- Keywords
- Oncolytic Virus, Revottack, PD-1(Toripalimab), Intravenous Injection, immunotherapy, immune Checkpoint Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Dec 2022 (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.
This is a one arm, open clinical pharmacological exploration study initiated by researchers to evaluate the safety and effectiveness of vesicular stomatitis oncolytic virus injection (Revottack) combined with PD-1 inhibitor in patients with advanced malignant solid tumors.
The purpose of this study is to evaluate the safety, tolerability, anti-tumor activity, immunogenicity, immune response, pharmacokinetic (PK) characteristics and shedding characteristics of Revottack injection combined with PD-1 inhibitor in patients with advanced solid tumors.
Detailed description
This is a one arm, open clinical pharmacological exploration study initiated by researchers to evaluate the safety and effectiveness of vesicular stomatitis oncolytic virus injection (Revottack) combined with PD-1 inhibitor in patients with advanced malignant solid tumors.
This study is planned to enroll 6-10 patients with advanced solid tumors. Subjects will receive the administration of revottack and PD-1( Toripalimab)inhibitor at a given time.
The purpose of this study is to evaluate the safety, tolerability, anti-tumor activity, immunogenicity, immune response, pharmacokinetic (PK) characteristics and shedding characteristics of Revottack injection combined with PD-1 inhibitor in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncolytic Virus Injection（Revottack）+PD-1 | Experimental | Biological: Oncolytic Virus Injection（Revottack）+PD-1In the first three cycles, the subjects were administered on the first day and the sixth day of each cycle respectively; At the beginning of the fourth cycle, the subjects were administered on the sixth day of each cycle, 14 days a cycle. PD-1 inhibitor(Toripalimab) Intravenous infusion, once every 2 weeks from the 6th day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The age at the time of signing the informed consent is ≥ 18 years old, regardless of gender;
- Patients with advanced malignant solid tumor confirmed by histology or cytology; Failure in standard treatment (disease progression or intolerable treatment after treatment) and no effective treatment means, or no standard treatment scheme, or inability to obtain standard treatment due to objective conditions.
- According to RECIST 1.1, there is at least one assessable tumor focus with the longest diameter ≥ 10mm (if it is a malignant lymph node, the short diameter ≥ 15mm is required);
- ECOG physical strength score 0-2;
- Full organ function:
Key exclusion criteria (23 listed)
- Patients with active CNS metastasis and/or carcinomatous meningitis are known or found during screening. However, the following subjects are allowed to be included in the group: ① Patients with asymptomatic brain metastasis (that is, patients without progressive central nervous system symptoms caused by brain metastasis do not need to use corticosteroids) can participate. ② Subjects who had been treated and had stable brain metastases for at least 2 months had no evidence of new or expanded brain metastases.
- He received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatments within 2 weeks before the first use of the study drug;
- Participated in other unlisted clinical studies within 4 weeks before the first use of the study drug;
- Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks before the first use of the study drug, or major elective surgery required during the study period.
- Patients who received systemic corticosteroids (prednisone>10mg/day or equivalent dose of the same drug) or other immunosuppressants within 14 days before the first use of the study drug; The following cases are excluded: local, eye, intra articular and intranasal corticosteroids are used for treatment; Short term use of corticosteroids for prevention and treatment;
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 |
|---|---|---|
| Oncolytic Virus Injection（Revottack）+PD-1Intravenous injection of Revottack injection combined with PD-1(Toripalimab） inhibitor | Biological | Oncolytic Virus Injection（Revottack）+PD-1 |
Primary outcome
Incidence of adverse events
Time frame: Up to 6 months
Graded according to the NCI CTCAE version 5.0.
Objective response rate
Time frame: Up to 2 years
Assess the proportion of patients who achieved complete or partial response
Disease control rate
Time frame: Up to 2 years
Assess the proportion of patients who achieved complete or partial or stable response
The changes from baseline of lymphocyte counts
Time frame: Up to 28 days
The changes from baseline of Peripheral blood lymphocyte subtypes counts
The concentration of antiviral antibody
Time frame: Up to 22 Weeks
The concentration of antiviral antibody of Revottack in blood
The rate of subjects with viral shedding of Revottack
Time frame: Up to 22 Weeks
The rate of subjects with viral RNA in the secretion
The Tmax of Viral RNA in blood
Time frame: Up to 22 Weeks
Time to peak viral RNA concentration
The Cmax of Viral RNA in blood
Time frame: Up to 22 Weeks
The peak viral RNA concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- 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. This study is not recruiting at the moment.
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 Oncolytic Virus Injection（Revottack）+PD-1 in people with Advanced Solid Tumor, run by The Affiliated Hospital of Xuzhou Medical University 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 23 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Zhengxiang, MD (18052268612, cnhzxyq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 6 months). The study lists 8 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 9 Dec 2022.