Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

Eligibility Criteria

• 1. Sign informed consent
• 2. Expected survival \> or = 3months
• 3. Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: Non-Small Cell Lung Cancer, HER2- breast cancer, esophageal cancer, Small Cell Lung Cancer, and Nasopharyngeal Cancer
• 4. Agree to provide a tumor sample
• 5. Has at least one measurable lesion based on RECIST 1.1
• 6. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
• 7. Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum or plasma amylase/lipase, and elevated blood glucose; except for toxicity that the investigator determined to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.)
• 8. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%.
• 9. Has adequate organ function before registration
• 10. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN
• 11. Urinary protein ≤2+ or ≤1000mg/24 hours
• 12. For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy must be negative and must be non-lactating
• 13. Must agree to use adequate barrier contraceptive measures during the treatment and 6 months after the end of treatment for all subjects (regardless of gender)
• 1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
• 2. Subjects with history of severe heart disease
• 3. Active autoimmune diseases and inflammatory diseases
• 4. Other malignant tumors were diagnosed within 5 years
• 5. Subjects with poorly controlled hypertension
• 6. Subjects have Grade 3 lung disease or a history of interstitial lung disease
• 7. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening
• 8. Symptoms of active central nervous system metastasis
• 9. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1
• 10. Subjects have a history of autologous or allogeneic stem cell transplantation
• 11. Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection
• 12. Subjects with active infections requiring systemic treatment
• 13. Participated in another clinical trial within 4 weeks prior to participating in the study
• 14. Other conditions that the investigator believes that it is not suitable for participating in this clinical trial
• 15. Subjects with prolonged QT interval (QTc \>470 msec), complete left bundle branch block, Grade 3 atrioventricular block
• 16. Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2