Advanced Pancreatic CancerPhase 1/2NCT05162118
Clinical Study of VG161 in Combination With Nivolumab in Subjects With Advanced Pancreatic Cancer
A Phase 1/2 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in combination with Nivolumab in people with Advanced Pancreatic Cancer, run by Zhejiang University at 1 site in China.
Trial summary
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This is a multicenter, open, single-arm design clinical trial coducted in HSV-seropositive subjects with advanced pancreatic cancer to determine the safety, tolerability and preliminary efficacy of VG161 combined with PD-1 inhibitor (Nivolumab… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in combination with Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2022to 22 Dec 2025
- 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 give informed consent to this study before the trial and voluntarily sign a written informed consent form
- Age 18 to 75 years (inclusive), male or female
- According to the Guidelines for the Diagnosis and Treatment of Pancreatic Cancer, patients with histologically or cytologically confirmed advanced primary pancreatic ductal adenocarcinoma, acinar cell carcinoma or adenosquamous carcinoma, accompanied by metastasis (TxNxM1), who have failed standard treatment, or have no effective treatment at this stage
- The presence of at least one intratumoral injection lesion with the longest diameter (the longest diameter of lymph nodes) greater than or equal to 1.5 cm that is required by the dose volume of the acceptable current dose group, including superficial lesions or deep lesions that can be injected under B ultrasound/CT guidance (such as liver metastases, etc.)
- Herpes simplex virus type I (HSV-1) antibody test results (HSV-1IgG or HSV-1IgM) are positive
- ECOG performance score 0-1
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- The expected survival time is 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 ≥ 75 × 10^9/L, Hb ≥ 90 g/L, lymphocyte count ≥ 1.5 × 10^9/L (for lymphocyte count 1.0 × 10^9/L to 1.5 × 10^9/L, the investigator judges whether it is necessary); 2) liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN (patients with liver metastases can receive ALT ≤ 5 × ULN, AST ≤ 5 × ULN); 3) Child-Pugh score: A-B; 4) renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml/min (calculated according to CockftGault formula); 5) coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN
- Eligible patients of childbearing potential (male and female) 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 medication; female patients of childbearing age must have a negative blood pregnancy test 7 days before inclusion
Who cannot join
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy (including PD-1/PD-L1 inhibitors) and other anti-tumor drug therapy 4 weeks before the first use of the study drug, oral fluoropyrimidines and small molecule targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer)
- Received other unmarketed clinical trial treatment 4 times before the first use of the study drug
- Major organ surgery (excluding needle biopsy) or significant trauma 4 times before the first use of study drugs; 4. 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 use of study drugs; except for the following conditions: the use of topical, ocular, intra-articular, intranasal and inhaled corticosteroids; short-term use of corticosteroids for prophylaxis (such as prevention of contrast agent allergy)
- Have received vaccination 4 times before the first use of the study drug
- The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except alopecia and other toxicities that are judged by the investigator to have no safety risk)
- Patients with central nervous system or spinal cord malignant tumors or metastases, which are not suitable for enrollment as judged by the investigator
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- Accompanied by spinal cord compression, which is not suitable for the investigator's judgment
- In the period of herpes simplex virus recurrence and infection, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on. 10.Other active uncontrolled infection
- History of immunodeficiency, including a positive HIV antibody test
- Patients with active hepatitis B or active hepatitis C. (Patients with hepatitis B virus carriers, stable hepatitis B after drug treatment [HBV-DNA negative] and cured hepatitis C [HCV RNA test negative]) were excluded. 13.History of severe cardiovascular disease: 1) arrhythmia requiring clinical intervention; 2) QTc interval > 480 ms; 3) acute coronary syndrome, congestive heart failure, stroke or other grade III and above cardiovascular events within 6 months; 4) New York Heart Association (NYHA) functional classification ≥ II or LVEF < 40%; 5) uncontrolled hypertension (judged by the investigator)
- Patients with active or previous autoimmune diseases that may relapse (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); patients with clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone, type I diabetes mellitus treated with stable doses of insulin, vitiligo or recovered childhood asthma/allergy, who do not require any intervention in adulthood
- Had received immunotherapy and experienced an irAE grade ≥ 3
- Known alcohol or drug dependence
- Patients with mental disorders or poor compliance
- Women who are pregnant or breastfeeding
- The subject has other serious systemic diseases or other reasons that make the subject unsuitable for this clinical study in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
TingBo Liang, MD, PHD, 086-571-87236688, liangtingbo@zju.edu.cn
About this study
Official title: Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of VG161 in Combination With Nivolumab in Patients With Advanced Pancreatic Cancer
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This is a multicenter, open, single-arm design clinical trial coducted in HSV-seropositive subjects with advanced pancreatic cancer to determine the safety, tolerability and preliminary efficacy of VG161 combined with PD-1 inhibitor (Nivolumab Injection).
Read the detailed description
A multicenter, open, single-arm design of clinical trial of VG161 in combined with PD-1 inhibitor (Nivolumab) in the treatment of patients with advanced pancreatic cancer with metastasis. The standard 3 + 3 design was used in the dose-finding study to explore the safety of the combination treatment, determine the recommended safe dose (RP2D) of the combination treatment in the second phase of efficacy study. The first cycle was observed until Day 28, i.e., DLT observation period. In the efficacy investigation trial, Simon two-segment design was used to continue to investigate the preliminary efficacy of the combination at a safe dose.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in combination with Nivolumab
- Keywords
- Solid Tumor
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)) in combination with NivolumabDrug
Also called VG161 + Nivolumab
Intratumoral injection of VG161 on day 1 only or day 1 through 3, in combination of Nivolumab intravenous injection only, Once every 2 weeks, 3 mg/kg each time.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | 1. Intratumoral injection of VG161 - 1.5*10^8 on D1 + Nivolumab on D8, D22
2. Intratumoral injection of VG161 - 1.0*10^8 on D1, D2 + Nivolumab on D8, D22
3. Intratumoral injection of VG161 - 1.0*10^8 on D1, D2, D3 + Nivolumab on D8, D22 Receives: Drug: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in combination with Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
MTD (Maximum tolerable dose)
Measured: 1 month
Occurrence and numbers of DLT (phase 1)
Occurence of DLT (Dose Limiting Toxicity) and numbers of DLT
Measured: 1 month
Occurence and frequence of AE and SAE (phase 1)
Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Measured: 24 month
DCR (phase 2)
Evaluate Disease Control Rate by RECIST 1.1
Measured: 24 month
RP2D (phase 1)
RP2D (Recommended dose for phase II)
Measured: 1 month
Secondary outcomes (19)
DCR (phase 1)
Evaluate Disease Control Rate by RECIST 1.1
Measured: 24 month
ORR
Evaluate Objective Response Rate by RECIST 1.1
Measured: 24 month
PFS
Evaluate Progression Free Survival by RECIST 1.1
Measured: 24 month
PD-1
PD-1 level in peripheral blood T cells
Measured: 24 month
Single cell sequencing
Single-cell sequencing of tumor biopsy samples
Measured: 24 month
Occurence and frequence of AE and SAE (phase 2)
Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Measured: 24 month
CD3+
Concentration of CD3+
Measured: 24 month
CD4+
Concentration of CD4+
Measured: 24 month
CD8+
Concentration of CD8+
Measured: 24 month
CD4+/CD8+
Concentration of CD4+/CD8+
Measured: 24 month
NK
Concentration of NK
Measured: 24 month
CD19+
Concentration of CD19+
Measured: 24 month
CD56+
Concentration of CD56+
Measured: 24 month
IL-6
Cytokine levels of IL-6
Measured: 24 month
TNF-a
Cytokine levels of TNF-a
Measured: 24 month
IFN-γ
Cytokine levels of IFN-γ
Measured: 24 month
CA19-9
Tumor markers of CA19-9
Measured: 24 month
CA125
Tumor markers of CA125
Measured: 24 month
CEA
Tumor markers of CEA
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start8 Mar 2022 (estimated)
- Primary completion22 Mar 2025 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
- Investigators
- Tingbo Liang, Doctor, Principal investigator, The First Affiliated Hospital Zhengjiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162118
- Sponsor's protocol ID
- VG161-IIS-201
- Status last verified
- Mar 2022
- First submitted
- 23 Nov 2021
- Last updated
- 9 Mar 2022
- Results posted
- 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 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of VG161 in Combination With Nivolumab in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05162118
- Acronym / sponsor ID
- VG161-IIS-201
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 8 Mar 2022 (estimated)
- Primary completion
- 22 Mar 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 17 Dec 2021 (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 Injectable. This is a multicenter, open, single-arm design clinical trial coducted in HSV-seropositive subjects with advanced pancreatic cancer to determine the safety, tolerability and preliminary efficacy of VG161 combined with PD-1 inhibitor (Nivolumab Injection).
Detailed description
A multicenter, open, single-arm design of clinical trial of VG161 in combined with PD-1 inhibitor (Nivolumab) in the treatment of patients with advanced pancreatic cancer with metastasis. The standard 3 + 3 design was used in the dose-finding study to explore the safety of the combination treatment, determine the recommended safe dose (RP2D) of the combination treatment in the second phase of efficacy study. The first cycle was observed until Day 28, i.e., DLT observation period. In the efficacy investigation trial, Simon two-segment design was used to continue to investigate the preliminary efficacy of the combination at a safe dose.
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)) in combination with Nivolumab1. Intratumoral injection of VG161 - 1.5*10^8 on D1 + Nivolumab on D8, D22 2. Intratumoral injection of VG161 - 1.0*10^8 on D1, D2 + Nivolumab on D8, D22 3. Intratumoral injection of VG161 - 1.0*10^8 on D1, D2, D3 + Nivolumab on D8, D22 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form
- Age 18 to 75 years (inclusive), male or female
- According to the Guidelines for the Diagnosis and Treatment of Pancreatic Cancer, patients with histologically or cytologically confirmed advanced primary pancreatic ductal adenocarcinoma, acinar cell carcinoma or adenosquamous carcinoma, accompanied by metastasis (TxNxM1), who have failed standard treatment, or have no effective treatment at this stage
- The presence of at least one intratumoral injection lesion with the longest diameter (the longest diameter of lymph nodes) greater than or equal to 1.5 cm that is required by the dose volume of the acceptable current dose group, including superficial lesions or deep lesions that can be injected under B ultrasound/CT guidance (such as liver metastases, etc.)
- Herpes simplex virus type I (HSV-1) antibody test results (HSV-1IgG or HSV-1IgM) are positive
Key exclusion criteria (16 listed)
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy (including PD-1/PD-L1 inhibitors) and other anti-tumor drug therapy 4 weeks before the first use of the study drug, oral fluoropyrimidines and small molecule targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer)
- Received other unmarketed clinical trial treatment 4 times before the first use of the study drug
- Major organ surgery (excluding needle biopsy) or significant trauma 4 times before the first use of study drugs; 4. 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 use of study drugs; except for the following conditions: the use of topical, ocular, intra-articular, intranasal and inhaled corticosteroids; short-term use of corticosteroids for prophylaxis (such as prevention of contrast agent allergy)
- Have received vaccination 4 times before the first use of the study drug
- The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except alopecia and other toxicities that are judged by the investigator to have no safety risk)
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)) in combination with NivolumabAlso: VG161 + NivolumabIntratumoral injection of VG161 on day 1 only or day 1 through 3, in combination of Nivolumab intravenous injection only, Once every 2 weeks, 3 mg/kg each time. | Drug | Single Arm |
Primary outcome
MTD
Time frame: 1 month
MTD (Maximum tolerable dose)
Occurrence and numbers of DLT (phase 1)
Time frame: 1 month
Occurence of DLT (Dose Limiting Toxicity) and numbers of DLT
Occurence and frequence of AE and SAE (phase 1)
Time frame: 24 month
Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
DCR (phase 2)
Time frame: 24 month
Evaluate Disease Control Rate by RECIST 1.1
RP2D (phase 1)
Time frame: 1 month
RP2D (Recommended dose for phase II)
19 secondary outcomes
DCR (phase 1)
Time frame: 24 month
ORR
Time frame: 24 month
PFS
Time frame: 24 month
PD-1
Time frame: 24 month
Single cell sequencing
Time frame: 24 month
Occurence and frequence of AE and SAE (phase 2)
Time frame: 24 month
CD3+
Time frame: 24 month
CD4+
Time frame: 24 month
CD8+
Time frame: 24 month
CD4+/CD8+
Time frame: 24 month
NK
Time frame: 24 month
CD19+
Time frame: 24 month
CD56+
Time frame: 24 month
IL-6
Time frame: 24 month
TNF-a
Time frame: 24 month
IFN-γ
Time frame: 24 month
CA19-9
Time frame: 24 month
CA125
Time frame: 24 month
CEA
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 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.
Tingbo Liang, Doctor principal investigator
The First Affiliated Hospital Zhengjiang University School of Medicine
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)) in combination with Nivolumab in people with Advanced Pancreatic Cancer, run by Zhejiang 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 9 inclusion and 16 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 Mar 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 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 Tingbo Liang, Doctor (13967159109, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: 1 month). The study lists 5 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 Mar 2022.