Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer

Exclusion Criteria

• •1\. History of allergic reactions attributed to any monoclonal antibody, and uncontrolled history of allergic asthma.
• •2\. Patients with other types of malignant tumours that have progressed or require treatment within 5 years prior to the screening, but well-treated skin basal cell carcinoma, skin squamous cell carcinoma, or superficial bladder cancer, and having cured carcinoma in situ, e.g. breast carcinoma in situ, can be accepted.
• •3\. Patients with any active autoimmune disease, but subjects with following diseases are allowed for further screening: subjects with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or who are not expected to relapse without external triggers.
• •4\. History of primary immunodeficiency.
• •5\. Patients with serious cardiovascular diseases, such as grade 2 or above heart failure based on the NYHA (New York Heart Association) Class guidelines, previous myocardial infarction within 3 months, poorly controlled arrhythmias or unstable angina pectoris, previous arterial or venous thrombosis events within 3 months (e.g. transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism).
• •6\. Has history of Interstitial Lung Disease (Patients caused by radiotherapy are eligible), or non-infectious pneumonitis need for glucocorticoid therapy.
• •7\. Have a history of active tuberculosis.
• •8\. Subjects with untreated or treated but still symptomatic central nervous system metastases (except for residual signs or symptoms related to CNS treatment, those with stable or improved neurological symptoms at least 2 weeks prior to screening can be included).
• •9\. Prior therapy with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways including anti-PD-1, anti-PD-L1, anti CTLA-4, OX40 agonist, and anti-CD137, etc.
• •10\. Immune-related adverse events of grade 3 or higher（NCI-CTCAE 5.0）after immune therapy.
• •11\. Have received major surgery or radical radiotherapy within 28 days, or palliative radiotherapy within 14 days, or radiological agents (strontium, samarium, etc.) within 56 days prior to screening.
• •12\. Have received systemic anti-tumour therapy 28 days before the first dose, including but not limited to chemotherapy, immunotherapy, macromolecular targeted therapy, and biological therapy (tumour vaccine, cytokines or growth factors controlling cancer); Patients who received small-molecule targeted and oral fluorouracil therapy within 14 days before the first dose.
• •13\. Have received attenuated live vaccine within 28 days before the first dose or planned to receive during the study period.
• •14\. Have received Chinese herbal medicine or Chinese patent medicine with anti-tumor activity within14 days prior to the first dose.
• •15\. Any active infection requiring systemic treatment by intravenous infusion within 28 days prior to the first dose.
• •16\. Have received systemic corticosteroids (at doses equivalent to or greater than 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose of study drug.
• •17\. Have participated other clinical trials and received related investigated drugs within 28 days prior to the first dose of study drug (counted from the date of the last treatment in the previous clinical trial, patients participated in the overall survival follow-up of the previous clinical trial can be accepted).
• •18\. Patients should be excluded if they have a positive test for human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-Ab). Patients with positive Hepatitis B virus surface antigen (HBsAg) and/or hepatitis B virus core antibody (HBcAb) as well quantitative HBV-DNA above upper limit of normal value, and patients with positive hepatitis C virus antibody (HCV-Ab) as well quantitative HCV-RNA above upper limit of normal value, should also be excluded.
• •19\. Pregnant or lactating women; Or the blood pregnancy test of women at child-bearing age is positive during screening.
• •20\. Other conditions that may increase the risk of drug use in the study, or interfere with the interpretation of the study results, or affect the compliance of the study, etc.