SarcomaPhase 2NCT06126510
Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
A Phase 2 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell) in people with Sarcoma, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 1 site in China.
Trial summary
This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcoma
- 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
- 40 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2023to 17 Jan 2026
- Phase
- Phase 2
- 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 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 old (inclusive), gender is not limited.
- Patients with advanced bone and soft tissue sarcoma confirmed by histopathological or cytology, who are unresectable by surgery and have failed at least one standard treatment (among them, patients with Ewing sarcoma need to be patients without standard treatment).
- According to RECIST 1.1, it is determined that at least one CT examination shows measurable and meets the volume requirement for the first injection, superficial lesions are preferred, and tumor lesions that can be injected under ultrasound guidance can also be selected (the injected lesions are preferably major tumor burden lesions), and the longest diameter of the injected lesion at baseline (short diameter for lymph node lesions) > 1.5cm.
- Those who have a positive HSV-1 IgG or HSV-1 IgM antibody test result (HSV-1 IgM).
- ECOG physical status score of 0-1.
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- Estimated survival time of more than 3 months.
- Have adequate organ function:
- Blood routine (no blood transfusion or colony-stimulating factor therapy within 14 days): ANC≥1.5×109/L, PLT≥75×109/L, Hb≥85g/L, lymphocyte count≥1.5×109/L (for lymphocyte count 0.8×109/L to 1.5×109/L at the discretion of the investigator);
- Liver function: TBIL ≤1.5×ULN, ALT≤3×ULN, AST≤3×ULN (ALT≤5×ULN and AST≤5×ULN are acceptable for patients with liver metastases);
- Renal function: Cr≤1.5×ULN, and creatinine clearance ≥45ml/min (calculated according to Cockcroft-Gault formula);
- Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR) ≤1.5×ULN.
- Eligible subjects (males and females) of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) for the duration of the trial and for at least 3 months after the last dose; Female patients of childbearing potential must have a negative blood pregnancy test within 7 days prior to enrollment.
Who cannot join
- Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of study drugs, among which oral fluorouracils and small molecule targeted drugs are the first use of study drugs. Within the first 2 weeks or the 5 half-lives of the drug (whichever is longer).
- Have received other unmarketed clinical trial treatments within 4 weeks before using the study drug for the first time.
- Have undergone major organ surgery (excluding puncture biopsy) or experienced significant trauma within 4 weeks before taking the study drug for the first time.
- Patients who have received systemic corticosteroids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressants within 14 days before the first use of study drugs; Exceptions are the following: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids (≤10 mg prednisone equivalent) for prophylactic treatment (e.g., prevention of contrast media allergy).
- Have received vaccination within 4 weeks before the first use of study drugs.
- The adverse reactions of previous anti-tumor treatments have not returned to CTCAE 5.0 grade ≤1 (except for toxicities such as hair loss that the researcher has judged to have no safety risks).
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- Patients with central nervous system metastasis or meningeal metastasis are not suitable for inclusion according to the investigator's judgment.
- With spinal cord compression, the researcher determines that the patient is not suitable for enrollment.
- In the period of recurrent infection of herpes simplex virus, with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, genital herpes, etc.
- Other uncontrolled active infections.
- Have a history of immunodeficiency, including positive HIV antibody test and 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 [negative HBV-DNA test or <50IU/ml] and cured hepatitis C patients [HCV RNA Tested negative]).
- Have a history of severe cardiovascular disease:
- Ventricular arrhythmias requiring clinical intervention;
- QTc interval>480ms;
- Acute coronary syndrome, congestive heart failure, stroke or other grade III or above cardiovascular events within 6 months before using the study drug for the first time;
- New York Heart Association (NYHA) cardiac function class ≥ class II or left ventricular ejection fraction (LVEF) <40%;
- Uncontrolled hypertension (systolic blood pressure ≥140mmHg, or diastolic blood pressure ≥90mmHg after treatment).
- Patients with active or past 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, etc.); but does not include patients with clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; Type I diabetes on insulin; patients with vitiligo or childhood asthma/allergies that have resolved and do not require any intervention in adulthood.
- Have received immunotherapy and experienced immune-related adverse events (irAEs) such as immune-related pneumonia, myocarditis, etc., which may affect the safety of the trial medication as judged by the researcher.
- Known dependence on alcohol or drugs.
- People with mental disorders or poor compliance.
- Pregnant or lactating women.
- Patients with obvious symptoms and unstable pleural effusion, peritoneal effusion or pericardial effusion (those with stable clinical symptoms after treatment of pleural effusion, ascites or pericardial effusion can be included).
- The researcher believes that the subject has other serious systemic diseases or other reasons and is not suitable to participate in this clinical study.
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
Peking University People's Hospital
Beijing
Lu Xie, Medical PhD, 13401044719, xie.lu@hotmail.com
About this study
Official title: A Single-arm, Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred.
Read the detailed description
This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred. If the subject VG161 injection target lesion shrinks after treatment and can no longer receive intratumoral injection administration of this administered dose of VG161, after evaluation by the investigator, it is allowed to reduce the dosing dose or suspend the administration as appropriate according to the size of the injectable lesion. After the end of treatment, there will also be an end-of-treatment visit and a post-treatment safety visit. Subjects who end the study for reasons not attributable to disease progression will undergo imaging evaluation at the end of treatment (if no imaging evaluation is performed within 4 weeks) and have imaging every 3 months after the end of treatment until disease progression or death or initiation of new anti-tumor therapy (whichever occurs first) to assess the time to disease progression. After the end of treatment, the subjects will also receive survival follow-up once every 3 months, and the survival status of the subjects and subsequent anti-tumor therapy will be collected and recorded until death, loss to follow-up or 1 year after the last dose (whichever occurs first).
- Conditions
- Sarcoma
- Being tested
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)
- Medical subject headings
- Sarcoma
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
VG161:1.0×10^8PFU/day, intratumoral injection administration for 3 consecutive days, 28 days as a cycle
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Single Arm | Experimental | VG161:1.0 × 10 ^ 8 PFU daily for 3 consecutive days on Days 1-3 of each cycle (D1-D3) 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.
ORR
Objective response rate (ORR)
Measured: through the study completion, an average of 2 year
4-month PFS rate
4-month Progression Free Survival (PFS) rate
Measured: through the study completion, an average of 2 year
6-month PFS rate
6-month Progression Free Survival (PFS) rate
Measured: through the study completion, an average of 2 year
Secondary outcomes (7)
DCR
disease control rate (DCR)
Measured: through the study completion, an average of 2 year
PFS
Progression Free Survival (PFS)
Measured: through the study completion, an average of 2 year
OS
Overall Survival (OS)
Measured: through the study completion, an average of 2 year
DOR
Duration of Response (DOR)
Measured: through the study completion, an average of 2 year
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 the study completion, an average of 2 year
6-month OS rate
6-month Overall Survival (OS) rate
Measured: through the study completion, an average of 2 year
12-month OS rate
12-month Overall Survival (OS) rate
Measured: through the study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start18 Jul 2023
- Primary completion17 Jul 2025 (estimated)
- Study completion17 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lu Xie, Medical PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126510
- Sponsor's protocol ID
- VG161-C206
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2023
- Last updated
- 24 Dec 2024
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT06126510
- Acronym / sponsor ID
- VG161-C206
- Conditions
- Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 17 Jul 2025 (estimated)
- Study completion
- 17 Jan 2026 (estimated)
- First posted
- 13 Nov 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.
This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred.
Detailed description
This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred. If the subject VG161 injection target lesion shrinks after treatment and can no longer receive intratumoral injection administration of this administered dose of VG161, after evaluation by the investigator, it is allowed to reduce the dosing dose or suspend the administration as appropriate according to the size of the injectable lesion. After the end of treatment, there will also be an end-of-treatment visit and a post-treatment safety visit. Subjects who end the study for reasons not attributable to disease progression will undergo imaging evaluation at the end of treatment (if no imaging evaluation is performed within 4 weeks) and have imaging every 3 months after the end of treatment until disease progression or death or initiation of new anti-tumor therapy (whichever occurs first) to assess the time to disease progression. After the end of treatment, the subjects will also receive survival follow-up once every 3 months, and the survival status of the subjects and subsequent anti-tumor therapy will be collected and recorded until death, loss to follow-up or 1 year after the last dose (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Single Arm | Experimental | Drug: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)VG161:1.0 × 10 ^ 8 PFU daily for 3 consecutive days on Days 1-3 of each cycle (D1-D3) |
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 give informed consent to this study before the trial and voluntarily sign a written informed consent form.
- Age 18 to 75 years old (inclusive), gender is not limited.
- Patients with advanced bone and soft tissue sarcoma confirmed by histopathological or cytology, who are unresectable by surgery and have failed at least one standard treatment (among them, patients with Ewing sarcoma need to be patients without standard treatment).
- According to RECIST 1.1, it is determined that at least one CT examination shows measurable and meets the volume requirement for the first injection, superficial lesions are preferred, and tumor lesions that can be injected under ultrasound guidance can also be selected (the injected lesions are preferably major tumor burden lesions), and the longest diameter of the injected lesion at baseline (short diameter for lymph node lesions) > 1.5cm.
- Those who have a positive HSV-1 IgG or HSV-1 IgM antibody test result (HSV-1 IgM).
Key exclusion criteria (25 listed)
- Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of study drugs, among which oral fluorouracils and small molecule targeted drugs are the first use of study drugs. Within the first 2 weeks or the 5 half-lives of the drug (whichever is longer).
- Have received other unmarketed clinical trial treatments within 4 weeks before using the study drug for the first time.
- Have undergone major organ surgery (excluding puncture biopsy) or experienced significant trauma within 4 weeks before taking the study drug for the first time.
- Patients who have received systemic corticosteroids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressants within 14 days before the first use of study drugs; Exceptions are the following: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids (≤10 mg prednisone equivalent) for prophylactic treatment (e.g., prevention of contrast media allergy).
- Have received vaccination within 4 weeks before the first use of study drugs.
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: VG161VG161:1.0×10^8PFU/day, intratumoral injection administration for 3 consecutive days, 28 days as a cycle | Drug | Experimental: Single Arm |
Primary outcome
ORR
Time frame: through the study completion, an average of 2 year
Objective response rate (ORR)
4-month PFS rate
Time frame: through the study completion, an average of 2 year
4-month Progression Free Survival (PFS) rate
6-month PFS rate
Time frame: through the study completion, an average of 2 year
6-month Progression Free Survival (PFS) rate
7 secondary outcomes
DCR
Time frame: through the study completion, an average of 2 year
PFS
Time frame: through the study completion, an average of 2 year
OS
Time frame: through the study completion, an average of 2 year
DOR
Time frame: through the study completion, an average of 2 year
Immunological indicators
Time frame: through the study completion, an average of 2 year
6-month OS rate
Time frame: through the study completion, an average of 2 year
12-month OS rate
Time frame: through the study completion, an average of 2 year
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 24 Dec 2024.
- 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.
Lu Xie, Medical PhD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell) in people with Sarcoma, 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 25 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 24 Dec 2024. 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 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?
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 Lu Xie, Medical PhD (13401044719, xie.lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: through the study completion, an average of 2 year). The study lists 3 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 Dec 2024.