Advanced Malignant Solid TumorPhase 1NCT04758897
Clinical Study of VG161 in Subjects With Advanced Malignant Solid Tumors
A Phase 1 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in people with Advanced Malignant Solid Tumor, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 2 sites in China.
Trial summary
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This Phase I study will be conducted in HSV-seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Malignant Solid Tumor
- What is being tested?
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- 14 Apr 2021to 1 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged within 18 to 80 years.
- Subject with late stage carcinoma which is refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists.
- There is at lease one injectable tumor lesion that meet the requirements of the assigned dose level. The superficial lesions are preferred, and the deep lesions that can be injected under the guidance of B ultrasound or computed tomography (CT) scan can also be selected.
- Eastern Cooperative Oncology Group (ECOG) scores 0 or 1.
- Life expectancy is at least 3 months.
- Required organ function:
Show all 9Show fewer
- 1) Hematology blood (no blood transfusion or colony stimulating factor treatment within 14 days): Absolute neutrophil count (ANC)≥1.5×10^9L, Platelets ( PLT)≥75×10^9L, hemoglobin (Hb)≥85g/L; 2) Liver function: Total Serum bilirubin (TBIL)≤1.5×ULN (the upper limit of the reference range), Alanine aminotransferase (ALT)≤3×ULN, aspartate aminotransferase (AST)≤3×ULN (acceptable for patients with liver metastasis or liver cancer: TBIL≤5×ULN, AST≤5×ULN, ALT≤5×ULN); 3) Renal function: Serum creatinine≤1.5×ULN, and creatinine clearance≥50 ml/min (calculated per Cockcroft-Gault formula); 4) Coagulation function: activated partial thromboplastin time (APTT)≤1.5×ULN, international standardized ratio (INR)≤1.5×ULN.
- 7. Subjects of childbearing potential (male and female) must agree to use a reliable contraceptive method (hormone or barrier method or abstinence) during the study and for at least 90 days following the last dose; females of childbearing potential must have a negative blood or urine pregnancy test within 7 days of study enrollment.
- 8. Signed written informed consent.
Who cannot join
- Subject in prior anti-tumor therapies such as chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy within 4 weeks of study treatment initiation.
- Participation in clinical trials of any other investigational agents within 4 weeks of study treatment initiation.
- Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks of study treatment initiation.
- Patients who received systemic treatment with either corticosteroids ( >10 mg/ daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.
- Subjects with any ≥Grade 1 toxicity (as per NCI CTC AE Version 5.0) related to prior anti-cancer therapy (except for toxicity that the investigator assessed to be no safety risk, such as alopecia.).
- Subjects with any uncontrolled active Central Nervous System (CNS) metastasis or meningeal metastasis with clinical symptoms.
Show all 15Show fewer
- Seronegative for Herpes Simplex Virus (HSV) (HSV-1IgG and HSV-1IgM).
- Subjects with the relapse of HSV infection and relevant clinical manifestations, such as lip herpes, herpes keratitis, herpes dermatitis, and genital herpes.
- Subjects with other uncontrolled active infections.
- Known history of immunodeficiency and test positive of human immunodeficiency virus (HIV).
- Active infection of hepatitis B (HBV) (hepatitis b virus titer higher than the detection limit or those requiring antiviral therapy), or hepatitis C virus (HCV).
- History of severe cardiovascular disease:
- 1)Ventricular arrhythmias requiring clinical intervention; 2)QTc interval >480 ms; 3)Acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events of III grade or above within 6 months; 4)The cardiac function grade≥II or left ventricular ejection fraction (LVEF) <50% per the New York Heart Association (NYA); 5)Uncontrolled hypertension. 13. Subjects with active or past autoimmune diseases that are likely to recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); acceptable for patients with clinically stable autoimmune thyroiditis.
- 14. Subjects with any prior ≥Grade 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent.
- 15. known to have alcohol or drug dependence. 16. Persons with mental disorders or poor compliance. 17. Pregnant or lactating women. 18. Subjects with any significant unrelated systemic illness that to the investigator's opinion would compromise the subject's eligibility to participate the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
ShangHai East hospital
Shanghai, Shanghai Municipality
Jin Li
- Recruiting
Xin Hua Hospital Affiliated to ShangHai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Wei Shen
About this study
Official title: A Dose Ascending, Open Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of VG161 in Subjects With Advanced Malignant Solid Tumors
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This Phase I study will be conducted in HSV-seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG161, and recommended dose of VG161 for Phase II trials.
Read the detailed description
The trial will be conducted in 7 dose ascending cohorts, including 3 single dose accelerated titration design pilots and 4 multiple dose escalation groups.
Descriptive statistics will be used to summarize all data.
- Conditions
- Advanced Malignant Solid Tumor
- Being tested
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))
- 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))Drug
Also called VG161
Intratumoral injection only. The dosing date can be the Day 1 only or Days 1 through 5.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | 1. 5.0*10^7 on D1
2. 1.0*10^8 on D1
3. 2.0*10^8 on D1
4. 2.0*10^8 on D1 and D2
5. 2.0*10^8 on Days 1 to 3
6. 2.0*10^8 on Days 1 to 4
7. 2.0*10^8 on Days 1 to 5 Receives: Drug: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD/RP2D
MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II)
Measured: 1 month
Occurence of DLT
Occurence of DLT (Dose Limiting Toxicity)
Measured: 1 month
Numbers of DLT
Numbers of DLT (Dose Limiting Toxicity)
Measured: 1 month
Occurence of AE and SAE（NCI CTCAE 5.0）
Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）
Measured: 7 months
Frequency of AE and SAE（NCI CTCAE 5.0）
Frequency of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）
Measured: 7 months
Secondary outcomes (9)
Tmax(h)
Time to peak
Measured: At the end of Cycle 1 (each cycle is 28 days)
Cmax(copies/ugDNA)
Maximum concentration
Measured: At the end of Cycle 1 (each cycle is 28 days)
ORR
Evaluate Objective Response Rate by RECIST 1.1.
Measured: 7 months
DCR
Evaluate Disease Control Rate by RECIST 1.1.
Measured: 7 months
mPFS
Evaluate medium Progression Free Survival by RECIST 1.1.
Measured: 7 months
CD3+, CD4+, CD8+
Concentration of CD3+, CD4+, CD8+
Measured: 7 months
IL15
Concentration of IL15
Measured: 7 months
PD-L1, PD-1
Concentration of PD-L1, PD-1,
Measured: 7 months
Existence of Biomarkers
PD-L1, Nectin2, HVEM
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start14 Apr 2021
- Primary completion14 Mar 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, doctor, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758897
- Sponsor's protocol ID
- VG161-C101
- Status last verified
- Apr 2021
- First submitted
- 9 Feb 2021
- Last updated
- 27 Apr 2021
- 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 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Ascending, Open Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of VG161 in Subjects With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT04758897
- Acronym / sponsor ID
- VG161-C101
- Conditions
- Advanced Malignant Solid Tumor
- Keywords
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 14 Mar 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 17 Feb 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 Phase I study will be conducted in HSV-seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG161, and recommended dose of VG161 for Phase II trials.
Detailed description
The trial will be conducted in 7 dose ascending cohorts, including 3 single dose accelerated titration design pilots and 4 multiple dose escalation groups.
Descriptive statistics will be used to summarize all data.
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))1. 5.0*10^7 on D1 2. 1.0*10^8 on D1 3. 2.0*10^8 on D1 4. 2.0*10^8 on D1 and D2 5. 2.0*10^8 on Days 1 to 3 6. 2.0*10^8 on Days 1 to 4 7. 2.0*10^8 on Days 1 to 5 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females aged within 18 to 80 years.
- Subject with late stage carcinoma which is refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists.
- There is at lease one injectable tumor lesion that meet the requirements of the assigned dose level. The superficial lesions are preferred, and the deep lesions that can be injected under the guidance of B ultrasound or computed tomography (CT) scan can also be selected.
- Eastern Cooperative Oncology Group (ECOG) scores 0 or 1.
- Life expectancy is at least 3 months.
Key exclusion criteria (15 listed)
- Subject in prior anti-tumor therapies such as chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy within 4 weeks of study treatment initiation.
- Participation in clinical trials of any other investigational agents within 4 weeks of study treatment initiation.
- Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks of study treatment initiation.
- Patients who received systemic treatment with either corticosteroids ( >10 mg/ daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.
- Subjects with any ≥Grade 1 toxicity (as per NCI CTC AE Version 5.0) related to prior anti-cancer therapy (except for toxicity that the investigator assessed to be no safety risk, such as alopecia.).
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. The dosing date can be the Day 1 only or Days 1 through 5. | Drug | Single Arm |
Primary outcome
MTD/RP2D
Time frame: 1 month
MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II)
Occurence of DLT
Time frame: 1 month
Occurence of DLT (Dose Limiting Toxicity)
Numbers of DLT
Time frame: 1 month
Numbers of DLT (Dose Limiting Toxicity)
Occurence of AE and SAE（NCI CTCAE 5.0）
Time frame: 7 months
Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）
Frequency of AE and SAE（NCI CTCAE 5.0）
Time frame: 7 months
Frequency of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）
9 secondary outcomes
Tmax(h)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Cmax(copies/ugDNA)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
ORR
Time frame: 7 months
DCR
Time frame: 7 months
mPFS
Time frame: 7 months
CD3+, CD4+, CD8+
Time frame: 7 months
IL15
Time frame: 7 months
PD-L1, PD-1
Time frame: 7 months
Existence of Biomarkers
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Advanced Malignant Solid Tumor
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingObservational study
Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program
Advanced Solid Tumor
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Jin Li, doctor principal investigator
Shanghai East Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in people with Advanced Malignant Solid Tumor, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 2 sites 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 15 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jin Li, doctor (13761222111, lijin@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD/RP2D (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 27 Apr 2021.