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

Inclusion Criteria:

• 1. Age ≥ 18 on the day of signing informed consent and volunteered to participated inthis study.
• 2. Histologically documented relapsed or metastatic uterine cervical cancer includingsquamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma, a relevantpathological report must also be provided.
• 3. Relapsed or metastatic uterine cervical cancer patient who has failed at leastfirst line platinum-based chemotherapy, which means having disease progression duringor following at least first line platinum based chemotherapy or for which platinumbased chemotherapy is not tolerated, having disease progression within 6 months of orduring neoadjuvant or adjuvant treatment with platinum based chemotherapy can also beaccepted.
• 4. Programmed Cell Death Ligand 1 (PD-L1) positive expression defined by CombinedPositive Score (CPS) ≥1.
• 5. All the subjects should have at least one measurable lesion in CT or MRI testassessed by RECIST 1.1. A previously irradiated site lesion could only be counted as atarget lesion if there was clear sign of progression since the irradiation.
• 6. If subjects have received anti-tumor therapies before, the toxicity severity mustdecrease to ≤ Grade1 evaluated by NCI-CTCAE 5.0, except for residual alopecia orfatigue.
• 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• 8. Has a predicted survival period ≥ 3 months assessed by investigators.
• 9. Demonstrate adequate organ function as defined below:

1. Blood routine tests (No blood transfusions were performed, no hematopoieticstimulators were used, and no drugs were used to correct blood cell counts ):Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets ≥75×109/L; Hemoglobin (HGB)≥9 g/dL;
2. Serum biochemical indexs: Serum creatinine ≤1.5 X ULN or Creatinine clearance (CCr) ≥ 50mL/min; Serum total bilirubin (TBIL) ≤ 1.5 X upper limit of normal ULN (Subjects with Gilbert's syndrome can be up to 3 x ULN); Aspartateaminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN or ≤5 X ULNfor subjects with hepatocellular carcinoma and liver metastases;
3. Coagulation function: Activated partial thromboplastin time (APPT) andInternational Normalized Ratio (INR)≤1.5 X ULN (No anticoagulants or other drugsaffecting clotting function were used within 14 days prior to the firstadministration, except for subjects requiring long-term anticoagulant therapy).

• 10. Women of child-bearing potential (WOCBP) should be willing to use reliablecontraceptive methods from signing the informed consent form to 6 months after lastdose of investigational drug.

Exclusion Criteria:

• 1. History of allergic reactions attributed to any monoclonal antibody, anduncontrolled history of allergic asthma.
• 2. Patients with other types of malignant tumours that have progressed or requiretreatment within 5 years prior to the screening, but well-treated skin basal cellcarcinoma, skin squamous cell carcinoma, or superficial bladder cancer, and havingcured carcinoma in situ, e.g. breast carcinoma in situ, can be accepted.
• 3. Patients with any active autoimmune disease, but subjects with following diseasesare allowed for further screening: subjects with well-controlled type I diabetes,well-controlled hypothyroidism with hormone replacement therapy, skin diseases (suchas vitiligo, psoriasis, or hair loss) without systemic treatment, or who are notexpected to relapse without external triggers.
• 4. History of primary immunodeficiency.
• 5. Patients with serious cardiovascular diseases, such as grade 2 or above heartfailure based on the NYHA (New York Heart Association) Class guidelines, previousmyocardial infarction within 3 months, poorly controlled arrhythmias or unstableangina pectoris, previous arterial or venous thrombosis events within 3 months (e.g.transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep veinthrombosis and pulmonary embolism).
• 6. Has history of Interstitial Lung Disease (Patients caused by radiotherapy areeligible), 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 systemmetastases (except for residual signs or symptoms related to CNS treatment, those withstable or improved neurological symptoms at least 2 weeks prior to screening can beincluded).
• 9. Prior therapy with any other antibody or drug specifically targeting T-cellco-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 immunetherapy.
• 11. Have received major surgery or radical radiotherapy within 28 days, or palliativeradiotherapy 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 targetedtherapy, and biological therapy (tumour vaccine, cytokines or growth factorscontrolling cancer); Patients who received small-molecule targeted and oralfluorouracil therapy within 14 days before the first dose.
• 13. Have received attenuated live vaccine within 28 days before the first dose orplanned to receive during the study period.
• 14. Have received Chinese herbal medicine or Chinese patent medicine with anti-tumoractivity 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 10mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to thefirst dose of study drug.
• 17. Have participated other clinical trials and received related investigated drugswithin 28 days prior to the first dose of study drug (counted from the date of thelast treatment in the previous clinical trial, patients participated in the overallsurvival follow-up of the previous clinical trial can be accepted).
• 18. Patients should be excluded if they have a positive test for humanimmunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-Ab).Patients with positive Hepatitis B virus surface antigen (HBsAg) and/or hepatitis Bvirus core antibody (HBcAb) as well quantitative HBV-DNA above upper limit of normalvalue, and patients with positive hepatitis C virus antibody (HCV-Ab) as wellquantitative 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-bearingage is positive during screening.
• 20. Other conditions that may increase the risk of drug use in the study, or interferewith the interpretation of the study results, or affect the compliance of the study,etc.