Bone and soft tissue sarcoma
Conditions
Interventions
intratumor injection:The investigational drug SGN1 will be administered by intratumoral injection once a week for 3 weeks, then discontinued for 1 week, every 28 days for 1 treatment cycle.
intravenous infusion:The investigational drug SGN1 will be administered by intravenous infusion once a week, every 4 weeks for one treatment cycle.
intra-arterial infusion:The investigational drug SGN1 will be administered by intra-arterial infusion once per 2 weeks, every 4 weeks for one treatment cycle.
Sponsors
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
3 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Inoperable advanced bone and soft tissue sarcoma patients aged 3-18 years, and inoperable advanced bone and soft tissue sarcoma patients aged 18-80 years who could not wait for the drug-eluting period due to their condition (no grade 2 or higher antitumor toxicity at the time of entry, Single index (such as R-glutaminase) grade 3 adverse reactions determined by the investigators did not affect the treatment of patients can also be included), both male and female; 2. ECOG score 0-1; 3. Patients with bone and soft tissue sarcoma were confirmed by clinicopathology; 4. Patients who can not be resected by surgery, chemical or radiotherapy progress (ASPS patients do not need first-line chemotherapy); 5. Have at least one measurable lesion according to the solid tumor response evaluation criteria (RECIST1.1); In addition, the tumor was confirmed by imaging examination and investigator assessment in advance that it did not invade the blood vessel wall or cavity organs (risk of massive bleeding or cavity perforation). 6. Expected survival >=3 months; 7. The main organ function and bone marrow function are normal, meeting the following requirements: (1) Hemoglobin >=90 g/L; (No blood transfusions within 14 days) (2) Absolute neutrophil count >=1.5×10^9/L; (3) Platelet count >=90×10^9/L; (4) Total bilirubin =50%; QTc Male < 450ms, female < 470ms; 8. International Normalized ratio of prothrombin time (INR) <=1.5, partial thromboplastin time (APTT) <=1.5 times ULN for patients who did not receive anticoagulant therapy. Patients receiving full or parenteral anticoagulant therapy as long as the anticoagulant dose is stable for at least 2 weeks prior to entering the clinical study and the results of the clotting test are within the limits of local treatment; 9. Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 3 months after the last administration of the study drug; For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and for 3 months after the last administration of the study drug; 10. Recovery from prior treatment: According to NCI-CTC AE Version 5.0, toxicity from prior treatment has been restored to <= grade 1 (except for non-clinically significant grade 2 or higher AE assessed by the investigator, and toxicity that has stabilized after treatment; If surgery is performed, the wound has completely healed); 11. The patient voluntarily participated in and signed the informed consent (or signed by the legal representative), and it is expected that the compliance is good and the patient can cooperate with the study according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1) Have received oncolytic virus or anti-tumor bacteria therapy; 2) Patients with great tumor burden or accompanied by cachexia; 3) Allergic to or intolerant to salmonella-sensitive antibiotics, or co-infectious diseases and currently taking antibiotics; 4) There are currently evaluable tumors in empty organs (stomach, esophagus, intestine, urethra, etc.); 5) Patients who are known to be allergic to the investigational drug or any of its excipients or emergency medications; Or have a severe allergic reaction to other monoclonal antibodies; 6) Patients who received the following treatments or drugs prior to first receiving the investigational drug therapy: a. Major surgery within 28 days prior to initial treatment with the investigational drug (biopsy for diagnostic purposes is permitted); b. Received immunosuppressive drugs (prednisone > 10 mg/ day, or equivalent corticosteroid) within 14 days prior to initial treatment with the study drug, Does not include corticosteroid nasal sprays and inhaled corticosteroids or systemic corticosteroids in physiological doses (i.e., not exceeding 10 mg/ day of prednisone or other corticosteroids in physiological doses equivalent); c. Vaccination with (attenuated) live virus vaccine: within 28 days before the first administration of the study drug, or during the study period, or 60 days after the last administration of the study drug; Except inactivated vaccines and RNA vaccines (such as inactivated influenza vaccines and COVID-19 RNA vaccines); 7) Patients with known uncontrolled or symptomatic active CNS metastasis characterized by clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pia meningeal disease, and/or progressive growth. Patients with a history of central nervous system metastasis or spinal cord compression who had been explicitly treated and showed stable clinical manifestations for 4 consecutive weeks after discontinuing anticonvulsants and steroids prior to the first administration of the study drug were included in the study. 8) Diverticulitis that may cause anaerobic bacteria to multiply or diseases that may promote the unexpected growth of anaerobic bacteria in non-target lesions at the time of screening; 9) Advanced symptomatic patients whose tumor has spread to the internal organs and is at risk of developing life-threatening complications in the short term, including uncontrolled mass accumulation of fluid [in the chest, pericardial cavity, or abdominal cavity]; 10) Patients with any active autoimmune disease or a history of any autoimmune disease with predictable recurrence (including, but not limited to: Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [patients whose disease can be controlled by hormone replacement therapy can be enrolled]; Patients with skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, hair loss, type 1 diabetes), or those with childhood asthma that has been in complete remission by adulthood and does not require intervention may be included. Patients with asthma requiring medical intervention with bronchodilators were excluded); 11) Patients with other active malignancies within 2 years prior to study entry. Patients with a history of cervical carcinoma in situ, superficial or non-invasive bladder carcinoma, or basal cell or squamous cell carcinoma in situ who had previously received radical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event,Serious Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR,DCR,PFS; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Outcome results
None listed