Soft tissue sarcoma
Conditions
Interventions
Experimental group:OVV-01?AK112
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the informed consent form, understand the study, agree to follow the protocol, and agree to complete all trial procedures; 2.Applicants must be at least 18 years of age at the time of signing the ICF; there are no gender restrictions. 3.Patients with histologically or cytologically confirmed metastatic or recurrent unresectable soft tissue sarcoma who have failed standard treatment (disease progression, recurrence, or intolerance to treatment, such as chemotherapy, radiation therapy, or targeted therapy) or for whom no standard treatment is available. Patients must have experienced disease progression after receiving at least two standard therapies (including, but not limited to, targeted therapies). Participants must have failed or been intolerant to at least one anthracycline-based standard chemotherapy regimen; for specific pathological subtypes lacking standard, effective chemotherapy options, such as alveolar soft tissue sarcoma, participants who have failed or been intolerant to prior targeted therapy [anti-angiogenic agents such as anlotinib, pazopanib, etc.] may be eligible. 4.Participants must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., a non-lymph node lesion with a longest diameter = 10 mm on CT or MRI, or a lymph node lesion with a shortest diameter = 15 mm. Additionally, the patient must have injectable tumor lesions, including superficial lesions, as well as deep lesions that can be injected under ultrasound, CT, or endoscopic guidance. 5.Participants with an ECOG performance status of 0–2 and an expected survival of at least 12 weeks. 6.Adequate organ and hematopoietic function: Absolute neutrophil count (ANC) = 1.5 × 10?/L; platelet count = 75 × 10?/L (no platelet transfusions or thrombopoietin [TPO] therapy within 2 weeks prior to the first dose); hemoglobin = 90 g/L (no blood transfusions within 2 weeks); Serum creatinine = 1.5 × upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) = 50 mL/min; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3.0 × ULN; for patients with liver metastases, AST and ALT < 5 × ULN; Serum total bilirubin (TBIL) = 2×ULN; International Normalized Ratio (INR) = 1.5×ULN, or activated partial thromboplastin time (APTT) = 1.5×ULN; 7.Women of childbearing age must take a pregnancy test within 7 days prior to starting treatment and receive a negative result. 8.Male and female participants of reproductive age must agree to use reliable contraception during the trial and for at least six months after the final dose.
Exclusion criteria
Exclusion criteria: 1.Patients with known brain metastases and/or clinically suspected brain metastases (however, patients with asymptomatic brain metastases or those clinically stable for over 3 months following local treatment may be enrolled); 2.Subjects who underwent radiotherapy to the target lesion within the past 2 months; 3.Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, or subjects with malignancies within the scope of the indication; 4.Lesions intended for injection with a maximum diameter >100 mm; 5.Participants who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks; 6.Participants scheduled for or who have previously undergone tissue/organ transplantation; 7.Participants with Human Immunodeficiency Virus (HIV) infection and opportunistic infections related to acquired immune deficiency (AIDS) within the past 12 months, or with a CD4+ T-cell (CD4+) count 10 mg/day of prednisone or equiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);duration of response (DoR);progression-free survival (PFS); overall survival (OS); | — |
Countries
China
Contacts
Public ContactNing Li
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed