Histologically or cytologically confirmed endometrial cancer
Conditions
Interventions
Test group:AK112 (Ivonescimab Injection), intravenous infusion, 20mg/kg, Q3W
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Agree to sign the informed consent form ICF. 2. 18 years old = 3 months. 8. At least one measurable lesion according to RECIST v1.1, and the lesion is suitable for repeated and accurate measurement according to RECIST v1.1. Radiotherapy-treated lesions that have progressed clearly and are measurable based on imaging judgment may be considered target lesions. 9. Good organ function as determined by the following requirements: a) Hematology (no use of any blood components and cell growth factor supportive therapy within 7 days prior to starting study treatment): i. Absolute neutrophil ANC >= 1.5 × 10^9/L (1,500/mm^3). ii. Platelet count >= 100 ×10^9/L (100,000/mm^3). iii. Hemoglobin>= 90 g/L. b) Kidney: i. Creatinine clearance * (CrCl) calculated >= 50 mL/min. * CrCl (Cockcroft-Gault formula) CrCL (mL/min) = [(140 - age ) × Weight (kg) × F]/ (SCr (mg/dL) × 72) F=0.85 (female) SCr = serum creatinine. ii. Urine protein < quantified < 1.0 g for 2 or 24 hours (h). c) Hepatic: i. Serum total bilirubin (TBil) <= 1.5 × ULN. ii. AST and ALT <= 2.5× ULN. d) Coagulation function: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 × ULN. 10. Female subjects of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail), and the result is negative. If a female subject of childbearing potential has sex with a male partner who is not sterilized, the subject must use an acceptable method of contraception from screening and must agree to use a contraceptive method continuously for 120 days after the last dose of study drug Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point. 11. Subject is willing and able to comply with the schedule of visits, treatment plan, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma or other high-grade sarcoma, or endometrial stromal sarcoma. 2. Previous (within 3 years) or at the same time other malignant tumors, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.). 3. Participated in treatment with an investigational drug or used an investigational device within 4 weeks prior to the first study administration. 3. Participated in treatment with an investigational drug or used an investigational device within 4 weeks prior to the first study administration. 4. Recurrent disease received systemic therapy other than chemotherapy, such as immune checkpoint inhibitors. 4. Recurrent disease received systemic therapy other than chemotherapy, such as immune checkpoint inhibitors. 5. Palliative local treatment for non-target lesions within 2 weeks prior to the first drug administration; receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, etc., excluding IL-11 used for the treatment of thrombocytopenia) within 2 weeks prior to the first drug administration; receipt of Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week prior to the first drug administration. 6. A history of active autoimmune diseases requiring systemic treatment (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. 7. A history of active or previous definite inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). 8. A history of immunodeficiency; positive HIV antibody test results; current long-term use of systemic corticosteroids or other immunosuppressants. 9. Known active tuberculosis (TB). Subjects with suspected active TB must undergo clinical examinations to rule out the condition; known active syphilis infection. 10. A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 11. A history of non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid treatment, or current non-infectious pneumonia. 12. Subjects with active hepatitis B (positive HBsAg and HBV-DNA exceeding 2000 copies/ml or the lower limit of detection, whichever is higher). Note: Subjects with hepatitis B are required to receive anti-hepatitis B virus treatment during the study. 13. Subjects with active hepatitis C (positive HCV antibody and HCV-RNA level higher than the lower limit of detection). 14. Major surgery or severe trauma within 30 days prior to the first drug administration, or plans for major surgery within 30 days after the first drug administration (as determined by the investigator); minor local surgery (excluding peripherally inserted central catheter placement and venous access port implantation) within 3 days prior to the first drug administration. 15. Presence of active central nervous system (CNS) metastatic lesions. Subjects with treated, asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroids, and no brain metastases with a longest diameter > 1.5 cm) may be enrolled, and brain metastases must be regularly evaluated dur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects (AE);Overall Survival (OS);Time to response (TTR);Duration of response (DoR);Disease control rate (DCR);Progression-free survival (PFS); | — |
Countries
China
Contacts
Public ContactLou Hanmei
Zhejiang Cancer Hospital
Outcome results
None listed