A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

Exclusion Criteria20

• Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
• History of severe heart disease;
• Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block;
• Active autoimmune and inflammatory diseases;
• Patients with other malignant tumors or a history of other malignant tumors;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• Patients with poor glycemic control;
• Patients with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD or current ILD, or suspicion of such disease during screening;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• Patients with primary central nervous system (CNS) tumors or CNS metastases that had failed local treatment;
• Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B16D1's excipients;
• Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• In previous (new) adjuvant anthracyclines, the cumulative dose of anthracyclines for doxorubicin \> 550 mg/m2, epirubicin \> 900 mg/m2 or the equivalent dose of other similar drugs;
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
• Serious infection occurred within 4 weeks before the first dose; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;
• Patients with massive or symptomatic effusions, or poorly controlled effusions;
• Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);
• Had the following eye diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. Contact lens dependence; e. Uncontrolled glaucoma; f. Uncontrolled or progressive retinopathy, wet macular degeneration, etc.;
• Other circumstances that the investigator deemed inappropriate for participation in the trial.