Solid Tumors
Conditions
Interventions
Test group:In this study, SGN1 will be injected into the target lesion intratumorally. According to the dose levels, the administered dose will be 0.5×10^8 CFU, 1×10^8 CFU, 2×10^8 CFU, 4×10^8 CFU, 6×1
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or females aged 18~75 years at the time of informed consent; 2. Part 1: Patients with advanced stage (unresectable or metastatic) cancer including but not limited to small cell lung cancer, non-small cell lung cancer (adeno- and squamous), Hodgkin’s lymphoma or non-Hodgkin’s lymphoma, sarcoma, cervical carcinoma, Melanoma, head and neck cancer, breast cancer, ovarian cancer, pseudomyxoma peritoneum (Pseudomyxoma peritonei, PMP) and hepatocellular carcinoma characterized by failure to standard treatment (disease progression or intolerance, such as chemotherapy, targeted therapy, and other immunotherapies) or patients who have no standard treatment options or patients who are intolerable to standard treatment; Note: For all tumor species included, standard treatment will refer to current Chinese Society of Clinical Oncology (CSCO)/National Comprehensive Cancer Network (NCCN) guidelines. Standard treatment failure refers to patients who have disease progression after the existing standard of care recommended by CSCO/NCCN guidelines, or relapse/metastasis after standard of care. Non-standard treatment refers to patients who have received the treatment recommended by the guidelines and currently have no other effective treatment options. 3. Part 2: the specific tumor-type expansion study may enroll the following patients: Patients with advanced HNSCC, Sarcoma, HCC, cervical cancer, melanoma, or other tumor type with potential efficacy signal observed in Part 1, who have failed standard therapy or who areintolerant to standard treatment; 4. Patients must have a main lesion suitable for local injection of SGN1. The tumors must be in situ or metastatic solid tumors that are subcutaneous, palpable, or can be injected directly using methods including but not limited to color doppler ultrasound guidance, which is the preferred method. If the Investigator(s) judge(s) it necessary, the tumor can also be injected under CT guidance by an interventional radiologist or specialist with adequate qualifications and trainings, provided that these tumors do not invade the walls of blood vessels or hollow organs confirmed by previous imaging studies. If there is liquefaction inside the tumor judged by the Investigator during treatment, it is recommended to use ultrasound to check the internal liquefaction of the tumor. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 6. Life expectancy = 12 weeks; 7. Patients have recovered from any toxic reaction to previous medications [=Grade 1 based on NCICTCAE v 5.0, except a. Hair loss; b. Pigmentation; c. The long-term toxicity caused by radiotherapy and cannot be recovered by the Investigator’s judgment; d. Platinum induced neurotoxicity of grade 2 and below; e. Hemoglobin at 90 ~ 100 g/L (including boundary value)] or stable status assessed by the Investigator. 8. At least one measurable lesion as determined by RECIST 1.1(for solid tumors); 9. Laboratory tests must meet the following requirements and patient must not have received any blood cell growth factor 14 days before the test and no blood transfusions within 14 days prior to screening (patients with laboratory values outside of the specified ranges will be permitted to be retested during the screening period in order to meet the criteria)]: a) absolute count of neutrophils (ANC) =1.5×109 /L, platelet =75×109 /L; Hemoglobin =90 g/L; b) serum albumin = 30 g/L; Bilirubin =1.5 × ULN, ALT and AST =2.5 × ULN; c) In patients with
Exclusion criteria
Exclusion criteria: 1. Prior treatment with oncolytic bacteria; 2. Patients with extremely large tumor (the longest diameter of a single tumor exceeds 8 cm); patients with multiple lesions cannot receive intratumoral injection, it mainly refers to patients with extensive metastasis who are not suitable for local treatment; 3. Patients who are allergic or intolerant to salmonella sensitive antibiotics, and have infectious diseases and are currently using antibiotics; 4. Present assessable tumors in hollow organs (stomach, esophagus, intestine, urinary tract etc.). 5. Patients who are known to be allergic to the investigational drug or any of its excipients, or rescue medications; or have a severe allergic reaction to other monoclonal antibodies; 6. Patients who have received the following treatments or drugs before the first treatment with the investigational drug: a) Major surgery performed within 28 days before the first treatment with the investigational drug (biopsy is allowed for diagnostic purposes); b) Immunosuppressive drugs have been administered within 14 days before the first treatment with the investigational drug (Prednisone >10 mg/day, Dexamethasone >1.5 mg/day), excluding corticosteroid nasal sprays and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., prednisone not exceeding 10 mg/d or equivalent physiological doses of other corticosteroids); c) Inoculation of (attenuated) live virus vaccine: within 28 days before the first dosing of study drug, or during the study period or 60 days after the last dose of study drug; d) Any anti-tumor therapies (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization) within 28 days before the first dosing of the investigational drug (if nitrosourea or mitomycin chemotherapy the interval between end of chemotherapy and first dose of study treatment must be no less than 6 weeks); 7. Patients with known uncontrollable or symptomatic active CNS metastases, manifested by clinical symptoms, brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease, and/or progressive growth. Patients with a history of metastases to the central nervous system or spinal cord compression can be included in the study if they have clearly received treatment and have shown stable clinical manifestations after the discontinuation of anticonvulsants and steroids for 4 weeks before the first dose of the investigational drug; 8. Present with diverticulitis or conditions at screening that might promote the unintentional growth of anaerobic bacteria in nontarget lesions; 9. Symptomatic, advanced patients whose tumors have spread to the internal organs and are at risk of life-threatening complications in the short term (including patients with uncontrollable large amounts of effusion (thoracic cavity, pericardial cavity, or abdominal cavity); 10. Patients with any active autoimmune diseases or a history of any autoimmune disease with predictable recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [only patients whose condition can be controlled by hormone replacement therapy can be included]; Patients with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, hair loss, Type I diabetes mellitus, or those with childhood asthma which has been completel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;PK; | — |
Countries
China
Contacts
Public ContactLi Zheng, Lei Liu
West China Hospital of Sichuan University
Outcome results
None listed