Bone and soft tissue sarcoma
Conditions
Interventions
Trial group:The administration method of OVV-01 injection is intratumoral injection, starting from day 1 of cycle 1 (C1D1), administered once every 2 weeks (Q2W), with a cycle of 2 weeks, and a dose o
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form, understand this study, be willing to follow the protocol, and complete all trial procedures; 2. Age >=18 years at the time of signing the ICF, regardless of gender. 3. Histologically or cytologically confirmed metastatic or recurrent unresectable soft tissue sarcoma, currently with failure of standard therapy (disease progression, recurrence, or intolerance, such as chemotherapy, radiotherapy, targeted therapy, etc.) or lacking standard treatment methods. Subjects must have progressed after receiving at least two standard treatments (including but not limited to targeted therapy). Subjects must have failed or been intolerant to at least one anthracycline-based standard chemotherapy regimen; for special pathological subtypes lacking standard and effective chemotherapy methods, such as alveolar soft part sarcoma, subjects who have failed or are intolerant to previous targeted medications [anti-angiogenic drugs such as anlotinib, pazopanib, etc.] are acceptable. 4. Subjects must have at least one measurable lesion as determined by RECIST 1.1, that is, non-lymph node lesions with a long diameter >=10 mm on CT or MRI, and lymph node lesions with a short diameter >=15 mm. The lesions must be injectable, including superficial lesions, as well as deep lesions that can be injected under ultrasound/CT/endoscopic guidance. 5. ECOG performance status score of 0-2, and expected survival of at least 12 weeks. 6. Adequate organ and hematopoietic function: (1) Absolute neutrophil count (ANC) >=1.5×10^9/L; (2) Platelets >=75×10^9/L (no platelet transfusion or thrombopoietin (TPO) treatment within 2 weeks before first dosing); (3) Hemoglobin >=90 g/L (no blood transfusion within 2 weeks); (4) Serum creatinine =50 mL/min; (5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3.0×ULN; if liver metastases are present, AST and ALT <5×ULN; (6) Total bilirubin (TBIL) <=2×ULN; (7) International normalized ratio (INR) <=1.5×ULN, or activated partial thromboplastin time (APTT) <=1.5×ULN; 7. Women of childbearing potential must undergo a pregnancy test within 7 days before starting treatment with a negative result. 8. Male and female subjects of reproductive potential must agree to use reliable contraception during the trial and for at least six months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Subjects known to have brain metastases and/or clinically suspected tumor brain metastases (patients with asymptomatic brain metastases or those clinically stable for more than 3 months after local treatment can be enrolled); 2. Subjects who have received radiotherapy on target lesions within the past 2 months; 3. Subjects with other active malignancies within the past 5 years, except those who have been completely cured and do not require follow-up treatment, or those with malignant tumors that fall within the indication scope; 4. Lesions intended for injection with a maximum diameter >100 mm; 5. Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks; 6. Subjects preparing for or having previously undergone tissue/organ transplantation; 7. Subjects infected with human immunodeficiency virus (HIV) with AIDS-related opportunistic infections within the past 12 months, or CD4 T-cell count =Grade 3 active infections with significant clinical relevance according to CTCAE v5.0; 11. Subjects who have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other antitumor drug treatments within 4 weeks before the first administration; have received small molecule targeted therapy and oral fluoropyrimidines within 2 weeks or 5 half-lives before first administration (whichever is longer); have taken herbal or traditional Chinese medicines with antitumor indications within 2 weeks before first administration; have received nitrosoureas or mitomycin C within 6 weeks before first administration; palliative radiotherapy for non-target lesions is allowed if >=2 weeks before first administration; 12. Subjects with drug-resistant hypertension or pulmonary hypertension, or unstable angina; history of myocardial infarction or bypass/stent surgery within 6 months before administration; history of chronic heart failure NYHA class 3-4; requiring treatment for serious arrhythmias (except for atrial fibrillation or paroxysmal supraventricular tachycardia judged by the investigator to have no impact on the trial), including QTcF >=450 ms for males or >=470 ms for females (calculated using Fridericia's formula); cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months before enrollment. 13. Patients with active autoimmune diseases or a history of autoimmune diseases that may relapse, but patients with the following conditions are not excluded and can be further screened: Type 1 diabetes; hypothyroidism (if it can be controlled only with hormone replacement therapy); controlled celiac disease; skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, alopecia); any other disease that will not recur without external triggers. 14. Subjects who require systemic corticosteroid treatment (>10 mg/day prednisone or equivalent) or other immunosuppressive dru
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Response duration;Progression-free survival;Overall survival;Incidence and characteristics of adverse events;Changes in safety indicators such as laboratory test results, physical examinations, electrocardiograms, and vital signs compared with baseline;VSV virus content in blood, urine, saliva, feces, and injection sites;Anti-VSV-G (IgG) antibody levels;Potential biomarkers in peripheral blood and tumor tissue that can predict efficacy (such as lymphocyte activation);Levels of cytokines such as IL-6 in the blood; | — |
Countries
China
Contacts
Public ContactHu Haiyan
Shanghai Sixth People's Hospital
Outcome results
None listed