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New treatment option for Sarcoma
Official title Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT06126510
What this study is testing
What is Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)?
Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for sarcoma.
Also referred to as VG161.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people 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...
- 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...
- Those who have a positive HSV-1 IgG or HSV-1 IgM antibody test result (HSV-1 IgM).
You likely can't join if
- Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4...
- 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...
- Patients who have received systemic corticosteroids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressants within...
- 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...
See the full eligibility criteria
Who can join
- people 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...
- 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...
- 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.
- 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...
- 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 people (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...
What rules you out
- 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...
- 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...
- 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).
- 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...
- 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...
- 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...
- The researcher believes that the subject has other serious systemic diseases or other reasons and is not suitable to participate in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.