Metastatic Gastric CancerPhase 1/2NCT06008925
Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer
A Phase 1/2 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) and Nivolumab Injection in people with Metastatic Gastric Cancer, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 1 site in China.
Trial summary
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection. This study will be conducted in combination with nivolumab injection in HSV seropositive subjects with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Gastric Cancer
- What is being tested?
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) and Nivolumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2022to Jun 2026
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (Subjects must meet all of the following inclusion criteria to enter the trial)
- Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.
- aged 18 to 75 years (inclusive), male or female.
- Patients with advanced metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology.
- According to the Guidelines for the Diagnosis and Treatment of Gastric Cancer (CSCO, version 2021), patients must have previously failed two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies), or patients who cannot continue treatment due to severe adverse reactions as judged by the investigator.
- Be able to provide paraffin blocks and/or tissue sections of previously archived pathological tissues, or willing to undergo tumor tissue biopsy before administration.
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- The presence of at least one measurable CT scan according to RECIST 1.1 and meeting the requirements for an acceptable injection dose volume (or the first injection dose volume in Phase IIa) in the current dose group, tumor metastases that can be injected under ultrasound guidance (injected lesions are best major tumor burden lesions), and the baseline longest diameter of the injected lesion (lymph node lesions are short diameters) > 1.5 cm.
- Positive test result for herpes simplex virus I antibodies (HSV-1 IgG or HSV-1 IgM).
- ECOG performance status score 0-1.
- Expected survival time of more than 3 months.
- adequate organ function: 1) blood routine (no blood transfusion or colony-stimulating factor treatment within 14 days): ANC ≥ 1.5 × 10^9/L, PLT ≥ 100 × 10^9/L, Hb ≥ 85 g/L, lymphocyte count ≥ 1.5 × 10^9/L (for lymphocyte count 0.8 × 10^9/L to 1.5 × 10^9/L, the investigator judged whether to enroll); 2) liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN; 3) renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml/min (calculated according to Cockcroft-Gault formula); 4) coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN.
- eligible subjects of childbearing potential (men and women) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose (VG161 or nivolumab, calculated at the later of the day).
- Female patients of childbearing age must have a negative blood pregnancy test within 1 day prior to enrollment.
Who cannot join
- (Any of the following criteria must be excluded)
- received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of the study drug, of which oral fluorouracil and small molecule targeted drugs were within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer).
- received other unmarketed clinical trial treatment within 4 weeks before the first dose of study drug.
- Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose of study drug.
- Patients who have received systemic corticosteroids (prednisone > 10 mg/day or equivalent doses of the same class of drugs) or other immunosuppressive agents within 14 days before the first dose of study drug; except for the following: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term corticosteroids (≤ 10 mg prednisone equivalent) for prophylaxis (e.g., prevention of contrast agent allergy).
- Vaccination within 4 weeks prior to the first dose of study drug.
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- Adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except alopecia and other toxicities judged by the investigator as having no safety risk).
- Patients with central nervous system metastasis, spinal cord metastasis and/or spinal cord compression.
- patients with active diverticulitis or symptomatic gastrointestinal ulcers;
- in the herpes simplex virus recurrence infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpes keratitis herpeticum, genital herpes, etc., or there are herpes infection-related complications (herpes keratitis, encephalitis, nerve injury, etc.), and intermittent or long-term use of anti-herpes drugs (e.g., acyclovir) treatment, except intermittent local use.
- other active uncontrolled infections.
- History of immunodeficiency, including positive HIV antibody test and positive Treponema pallidum antibody test.
- Patients with active chronic hepatitis B or active hepatitis C (except hepatitis B virus carriers, stable hepatitis B after drug treatment [HBV-DNA test negative or < 50 IU/ml] and cured hepatitis C patients [HCV RNA test negative]);
- history of serious cardiovascular disease: 1) ventricular arrhythmia requiring clinical intervention; 2) QTc interval > 480 ms; 3) Acute coronary syndrome, congestive heart failure, stroke or other Grade III or higher cardiovascular events within 6 months; 4) New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) < 40%; 5) uncontrolled hypertension after treatment (as judged by the investigator).
- Patients with active, or have had and have had autoimmune diseases that may recur (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes, etc.); but excluding patients with clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type I diabetes using stable doses of insulin; vitiligo or recovered childhood asthma/allergy, and patients who do not require any intervention in adulthood.
- Having received immunotherapy and have experienced immune-related adverse events (irAEs) such as immune-related pneumonia and myocarditis, which may affect the safety of the investigational drug as judged by the investigator.
- Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.
- Known alcohol or drug dependence.
- Mental disorders or poor compliance.
- Pregnant or lactating women.
- subjects with pleural effusion or pericardial effusion or ascites requiring clinical intervention.
- The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality
About this study
Official title: A Dose Ascending, Open Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of VG161 Combined With Nivolumab Injection in Subjects With Metastatic Gastric Cancer
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection. This study will be conducted in combination with nivolumab injection in HSV seropositive subjects with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies). This is an open-label study divided into two parts.
Part 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination.
Part 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.
Read the detailed description
Part1(Phase Ib primary objective): To evaluate the safety and tolerability of VG161 administered by intratumoral injection combined with Nivolumab Injection in the treatment of patients with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (including anti-PD-1 monoclonal antibodies), explore the most suitable recommended Phase II dose (RP2D) for combination therapy, and determine the recommended regimen for combination therapy in Phase IIa clinical trials. Secondary objectives: 1) To preliminarily evaluate the antitumor activity of VG161 combined with nivolumab injection in the treatment of patients with advanced gastric cancer; 2) To monitor the changes of immunological parameters related to pharmacodynamics; 3) To evaluate the relevant immunological characteristics of tumor biopsy samples; 4) To evaluate the pharmacokinetic (PK) characteristics and viral excretion of single and multiple intratumoral injections of VG161;
Part2(Phase IIa Primary Objective): To further evaluate the safety and efficacy of intratumoral injection of VG161 combined with nivolumab injection in patients with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies), with the primary outcome measure of efficacy being objective response rate (ORR). Secondary objectives: 1) To evaluate the secondary outcome measures of the efficacy of combined treatment; 2) To monitor the pharmacodynamic-related changes in immunological parameters; 3) To evaluate the relevant immunological characteristics of tumor biopsy samples;
- Conditions
- Metastatic Gastric Cancer
- Being tested
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)), Nivolumab Injection
- Keywords
- Gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))Drug
Also called VG161
Intratumoral injection only. Dosing days may be Day 1 or Days 1-3 only.
Nivolumab InjectionDrug
Also called OPDIVO
Administered once at 3 mg/kg intravenously on Days 8 and 22 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Part1:
VG161:
1) 1.0 × 10 ^ 8 PFU daily on Day 1 of each cycle (D1); 2)1.0 × 10 ^ 8 PFU daily for 2 consecutive days on Days 1-2 of each cycle (D1-D2); 3)1.0 × 10 ^ 8 PFU daily for 3 consecutive days on days 1-3 (D1-D3) in the first cycle; 1.0 × 10 ^ 8 PFU daily for 2 consecutive days on days 1-2 (D1-D2) in the second and subsequent cycles; Nivolumab Injection: 3 mg/kg every 2 weeks (D8, D22)
Part2:
Depends on the recommended dose in Part1 Receives: Drug: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)); Drug: Nivolumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib:RP2D/MTD
RP2D/MTD for VG161 in Combination with Nivolumab
Measured: through Phase Ib study completion, an average of 1 year
Phase Ib:Incidence and number of DLT
Incidence and number of DLT (dose-limiting toxicity)
Measured: through Phase Ib study completion, an average of 1 year
Phase Ib and Phase IIa:AE, SAE occurrence and frequency
Occurrence and frequency of AE (Adverse Event) and SAE（Serious adverse event)
Measured: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase IIa:ORR
Objective response rate (ORR)
Measured: through Phase IIa study completion, an average of 1 year
Secondary outcomes (8)
Phase Ib and Phase IIa:ORR and DCR
Objective response rate (ORR) and disease control rate (DCR)
Measured: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa:PFSand OS
Progression Free Survival (PFS) and Overall Survival (OS)
Measured: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa:DOR
Duration of Response (DOR)
Measured: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa: Immunological indicators
Immunological parameters: peripheral blood lymphocyte subsets (CD3 +, CD4 +, CD8 +, CD4 +/CD8 + ratio, CD19 +, CD16 + CD56 + (NK) cells), cytokines (IL-12, IL-15, IL-6, TNF-α, IFN-γ);
Measured: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa:Correlation of PD-L1 combined positive score (CPS) with safety and efficacy
Correlation of PD-L1 combined positive score (CPS) with safety and efficacy
Measured: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa:Correlation of herpes simplex virus type I antibodies with safety and efficacy
Correlation of herpes simplex virus type I antibodies with safety and efficacy
Measured: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa:Immunohistochemical detection of HER2、CD68、 CD3、 CD4、 CD8、CD47
Immunohistochemical detection of HER2、CD68、 CD3、 CD4、 CD8、CD47
Measured: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib :Pharmacokinetic parameters: Blood concentrations of VG161 at different time points after single and multiple doses
Pharmacokinetic parameters: Blood concentrations of VG161 at different time points after single and multiple doses
Measured: through Phase Ib study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start17 Nov 2022
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Gastric CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008925
- Sponsor's protocol ID
- VG161-C202
- Status last verified
- Aug 2023
- First submitted
- 5 Mar 2023
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Ascending, Open Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of VG161 Combined With Nivolumab Injection in Subjects With Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT06008925
- Acronym / sponsor ID
- VG161-C202
- Conditions
- Metastatic Gastric Cancer
- Keywords
- Gastric cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Aug 2023 (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.
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection. This study will be conducted in combination with nivolumab injection in HSV seropositive subjects with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies). This is an open-label study divided into two parts.
Part 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination.
Part 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.
Detailed description
Part1(Phase Ib primary objective): To evaluate the safety and tolerability of VG161 administered by intratumoral injection combined with Nivolumab Injection in the treatment of patients with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (including anti-PD-1 monoclonal antibodies), explore the most suitable recommended Phase II dose (RP2D) for combination therapy, and determine the recommended regimen for combination therapy in Phase IIa clinical trials. Secondary objectives: 1) To preliminarily evaluate the antitumor activity of VG161 combined with nivolumab injection in the treatment of patients with advanced gastric cancer; 2) To monitor the changes of immunological parameters related to pharmacodynamics; 3) To evaluate the relevant immunological characteristics of tumor biopsy samples; 4) To evaluate the pharmacokinetic (PK) characteristics and viral excretion of single and multiple intratumoral injections of VG161;
Part2(Phase IIa Primary Objective): To further evaluate the safety and efficacy of intratumoral injection of VG161 combined with nivolumab injection in patients with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies), with the primary outcome measure of efficacy being objective response rate (ORR). Secondary objectives: 1) To evaluate the secondary outcome measures of the efficacy of combined treatment; 2) To monitor the pharmacodynamic-related changes in immunological parameters; 3) To evaluate the relevant immunological characteristics of tumor biopsy samples;
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)), Drug: Nivolumab InjectionPart1: VG161: 1) 1.0 × 10 ^ 8 PFU daily on Day 1 of each cycle (D1); 2)1.0 × 10 ^ 8 PFU daily for 2 consecutive days on Days 1-2 of each cycle (D1-D2); 3)1.0 × 10 ^ 8 PFU daily for 3 consecutive days on days 1-3 (D1-D3) in the first cycle; 1.0 × 10 ^ 8 PFU daily for 2 consecutive days on days 1-2 (D1-D2) in the second and subsequent cycles; Nivolumab Injection: 3 mg/kg every 2 weeks (D8, D22) Part2: Depends on the recommended dose in Part1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- (Subjects must meet all of the following inclusion criteria to enter the trial)
- Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.
- aged 18 to 75 years (inclusive), male or female.
- Patients with advanced metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology.
- According to the Guidelines for the Diagnosis and Treatment of Gastric Cancer (CSCO, version 2021), patients must have previously failed two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies), or patients who cannot continue treatment due to severe adverse reactions as judged by the investigator.
Key exclusion criteria (22 listed)
- (Any of the following criteria must be excluded)
- received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of the study drug, of which oral fluorouracil and small molecule targeted drugs were within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer).
- received other unmarketed clinical trial treatment within 4 weeks before the first dose of study drug.
- Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose of study drug.
- Patients who have received systemic corticosteroids (prednisone > 10 mg/day or equivalent doses of the same class of drugs) or other immunosuppressive agents within 14 days before the first dose of study drug; except for the following: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term corticosteroids (≤ 10 mg prednisone equivalent) for prophylaxis (e.g., prevention of contrast agent allergy).
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 |
|---|---|---|
| Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))Also: VG161Intratumoral injection only. Dosing days may be Day 1 or Days 1-3 only. | Drug | Single Arm |
| Nivolumab InjectionAlso: OPDIVOAdministered once at 3 mg/kg intravenously on Days 8 and 22 of each cycle. | Drug | Single Arm |
Primary outcome
Phase Ib:RP2D/MTD
Time frame: through Phase Ib study completion, an average of 1 year
RP2D/MTD for VG161 in Combination with Nivolumab
Phase Ib:Incidence and number of DLT
Time frame: through Phase Ib study completion, an average of 1 year
Incidence and number of DLT (dose-limiting toxicity)
Phase Ib and Phase IIa:AE, SAE occurrence and frequency
Time frame: through Phase Ib and Phase IIa study completion, an average of 2 year
Occurrence and frequency of AE (Adverse Event) and SAE（Serious adverse event)
Phase IIa:ORR
Time frame: through Phase IIa study completion, an average of 1 year
Objective response rate (ORR)
8 secondary outcomes
Phase Ib and Phase IIa:ORR and DCR
Time frame: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa:PFSand OS
Time frame: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa:DOR
Time frame: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa: Immunological indicators
Time frame: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa:Correlation of PD-L1 combined positive score (CPS) with safety and efficacy
Time frame: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa:Correlation of herpes simplex virus type I antibodies with safety and efficacy
Time frame: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib and Phase IIa:Immunohistochemical detection of HER2、CD68、 CD3、 CD4、 CD8、CD47
Time frame: through Phase Ib and Phase IIa study completion, an average of 2 year
Phase Ib :Pharmacokinetic parameters: Blood concentrations of VG161 at different time points after single and multiple doses
Time frame: through Phase Ib study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- 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.
Lin Shen principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) and Nivolumab Injection in people with Metastatic Gastric Cancer, run by CNBG-Virogin Biotech (Shanghai) Ltd. 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 13 inclusion and 22 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 24 Aug 2023. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lin Shen, Professor (13911219511 ext. 010-88196561, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib:RP2D/MTD (time frame: through Phase Ib study completion, an average of 1 year). The study lists 4 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 24 Aug 2023.