A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

Exclusion Criteria

• •1. Anti-tumor therapy such as chemotherapy, biological therapy, and immunotherapy had been used within 4 weeks or 5 half-lives before the first dose. Oral drugs such as fluorouracil;
• •2. Prior ADC drug therapy with camptothecin derivative as toxin;
• •3. The history of severe cardiovascular and cerebrovascular diseases in the past six months;
• •4. Serious impairment of lung function due to pulmonary diseases;
• •5. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• •6. Other primary malignancies diagnosed within 5 years before the first dose;
• •7. Poorly controlled hypertension;
• •8. A history of ILD requiring steroid therapy, current ILD/interstitial pneumonia or suspected to have such a condition during screening;
• •9. Patients with active central nervous system metastases;
• •10. Patients who are allergic to any excipients of the trial drug;
• •11. Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing;
• •12. Patients with massive or symptomatic effusions or poorly controlled effusions;
• •13. Severe systemic infection within 4 weeks before screening;
• •14. Active autoimmune and inflammatory diseases;
• •15. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
• •16. Previous history of allogeneic stem cell, bone marrow or organ transplantation;
• •17. A history of severe neurological or psychiatric illness;
• •18. Pregnant or lactating women;
• •19. The presence of other serious physical or laboratory abnormalities or poor compliance may increase the risk of participating in the study risk, or interference with the results of the study, and patients who were deemed by the investigators to be unsuitable for participation in the study.