Actively Recruiting
Study of VG161 Injection Administered Into Tumors for Advanced Bone and Soft Tissue Sarcoma A Single-Arm Phase IIa Trial Evaluating VG161's Safety and Effectiveness
Led by CNBG-Virogin Biotech (Shanghai) Ltd. · Updated on 2024-12-24
40
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VG161, a recombinant human IL12/15-PDL1B oncolytic HSV-1 injection, for treating advanced bone and soft tissue sarcoma in adults aged 18 to 75 years. This phase IIa, single-arm, multicenter, open-label study aims to assess the efficacy and safety of VG161 in patients who have tumors that are unresectable and have failed at least one standard treatment. The study focuses on sarcoma patients with measurable lesions suitable for intratumoral injection, and who meet specific health and organ function criteria. Participants receive VG161 at a dose of 1.0x10^8 PFU per day through intratumoral injections for 3 consecutive days, with each treatment cycle lasting 28 days. Tumor imaging evaluations are conducted every 8 plus or minus 1 weeks starting from the first dose to monitor response and determine treatment continuation. Dose adjustments or pauses may be made if the target lesion shrinks and is no longer suitable for injection. After treatment ends, patients have an end-of-treatment visit and a safety follow-up visit. Throughout the study, participants undergo regular imaging to assess tumor progression every 3 months after treatment completion if no progression occurs, continuing until disease progression, death, or new anti-tumor therapy begins. Survival follow-up also occurs every 3 months to record survival status and subsequent therapies for up to one year after the last dose or until loss to follow-up or death. The primary outcomes measured include overall response rate and progression-free survival rates at 4 and 6 months over an average 2-year study period.
CONDITIONS
Official Title
Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must give informed consent and voluntarily sign a written form
- Age 18 to 75 years old, any gender
- Diagnosed with advanced bone or soft tissue sarcoma confirmed by pathology or cytology, unresectable by surgery, and failed at least one standard treatment (Ewing sarcoma patients must have no standard treatment options)
- At least one measurable tumor lesion suitable for intratumoral injection, with longest diameter over 1.5 cm
- Positive HSV-1 IgG or IgM antibody test
- ECOG physical status score 0-1
- Estimated survival time over 3 months
- Adequate organ function based on blood counts, liver, kidney, and coagulation tests
- Agree to use reliable contraception during the trial and for at least 3 months after last dose; female participants of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
You will not qualify if you...
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor drugs within 4 weeks before first study drug dose (with some exceptions for oral fluorouracil and small molecule targeted drugs)
- Participated in other unmarketed clinical trials within 4 weeks before first study drug dose
- Had major organ surgery or significant trauma within 4 weeks before first study drug dose
- Used systemic corticosteroids over 10 mg prednisone/day or other immunosuppressants within 14 days before first study drug dose (with exceptions for certain topical or short-term uses)
- Received vaccination within 4 weeks before first study drug dose
- Previous anti-tumor treatment adverse reactions not resolved to grade 1 or lower (except hair loss)
- Presence of central nervous system or meningeal metastasis as judged unsuitable by investigator
- Spinal cord compression deemed unsuitable for enrollment
- Active herpes simplex virus infection with clinical symptoms
- Other uncontrolled active infections
- History of immunodeficiency, including positive HIV or syphilis antibody tests
- Active chronic hepatitis B or C except stable or cured cases
- Severe cardiovascular disease including certain arrhythmias, recent acute coronary events, heart failure, or uncontrolled hypertension
- Active or past autoimmune diseases prone to relapse, excluding some stable or treated conditions
- History of immune-related adverse events from immunotherapy affecting safety
- Known dependence on alcohol or drugs
- Mental disorders or poor compliance
- Pregnant or lactating women
- Unstable pleural, peritoneal, or pericardial effusions
- Other serious systemic diseases or conditions deemed unsuitable by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
L
Lu Xie, Medical PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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