IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial

Exclusion Criteria

• •1. Patients with cervical cancer histologically diagnosed as squamous cell carcinoma, usual-type adenocarcinoma, clear cell carcinoma, adenosquamous carcinoma, small cell carcinoma, or any non-gastric-type adenocarcinoma.
• •2. Participate in other drug clinical trials at the same time.
• •3. Known hypersensitivity to any component of the IN10018 formulation or to cadonilimab.
• •4. Patients with active autoimmune disease or a history of autoimmune disorders.
• •5. Patients with concomitant conditions requiring immunosuppressive medications or systemic or absorbable local corticosteroids at immunosuppressive doses. The use of prednisone \>10 mg/day or an equivalent dose is prohibited within 2 weeks prior to the first administration of the investigational drug.
• •6. HIV infection or a positive test for acquired immunodeficiency syndrome (AIDS).
• •7. Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• •8. Necrotic lesions identified within 4 weeks prior to enrollment, where there is a high risk of major bleeding as determined by the investigator.
• •9. Severe infections occurring within 4 weeks prior to the first dose of study treatment.
• •10. Known active tuberculosis (TB) or suspicion of active TB.
• •11. Untreated chronic hepatitis B infection or hepatitis B virus (HBV) carriers with HBV DNA levels exceeding 1000 IU/mL, or patients with active hepatitis C infection.
• •12. Patients with known leptomeningeal disease, spinal cord compression, or active brain metastases.
• •13. Uncontrolled severe medical conditions that, in the investigator's judgment, would interfere with the patient's ability to receive study treatment, including but not limited to severe cardiovascular disease, cerebrovascular disease, uncontrolled diabetes, or uncontrolled infections.
• •14. Receipt of a live vaccine within 4 weeks prior to the first dose of study treatment. Note: Inactivated seasonal influenza vaccines are permitted.
• •15. Pregnant or breastfeeding female patients, or female patients of childbearing potential who refuse to use effective contraception.
• •16. Patients with symptomatic or unstable third-space fluid accumulations (e.g., pleural effusion, ascites, pericardial effusion) requiring repeated drainage.
• •17. Patients with a prior genetic test report indicating mutations associated with hyperprogression under immunotherapy, such as MDM2/4 amplification or EGFR mutations.