A Study of BL-B16D1 in Patients With Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria:

1. Sign the informed consent form voluntarily and follow the protocol requirements;

2. Gender is not limited;

3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);

4. Expected survival time ≥3 months;

5. locally advanced or metastatic solid tumors confirmed by histopathology and/orcytology that failed standard treatment or could not obtain standard treatment;

6. Consent to provide archival tumor tissue samples or fresh tissue samples fromprimary or metastatic lesions within 3 years;

7. At least one measurable lesion meeting the RECIST v1.1 definition was required;

8. ECOG 0 or 1;

9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as definedby NCI-CTCAE v5.0;

10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

11. The organ function level must meet the requirements if the patient has not receivedblood transfusion or hematopoietic stimulating factor therapy within 14 days beforescreening;

12. Coagulation function: international normalized ratio ≤1.5, and activated partialthromboplastin time ≤1.5ULN;

13. Urinary protein ≤2+ or ≤1000mg/24h;

14. For premenopausal women with childbearing potential, a pregnancy test must beperformed within 7 days before starting treatment, serum pregnancy must be negative,and the patient must not be lactating; All enrolled patients (male or female) shoulduse adequate contraception throughout the treatment cycle and for 6 months aftercompletion of treatment.

Exclusion Criteria:

1. Chemotherapy, biological therapy and other anti-tumor therapies have been usedwithin 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureaswere administered within 6 weeks before the first dose; Oral drugs such asfluorouracil;

2. History of severe heart disease;

3. Long QT, complete left bundle branch block, III degree atrioventricular block;

4. Active autoimmune and inflammatory diseases;

5. Other malignancies diagnosed within 5 years before the first dose;

6. Hypertension poorly controlled by two antihypertensive drugs;

7. Patients with poor glycemic control;

8. Present with grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition;Previous history of ILD or current ILD, or suspicion of such disease duringscreening;

9. Complicated with pulmonary diseases leading to clinically severe respiratoryfunction impairment;

10. Active central nervous system metastasis;

11. Patients with a history of allergy to recombinant humanized or human-mouse chimericantibodies or to any of the excipients of BL-B16D1;

12. Received previous organ transplantation or allogeneic hematopoietic stem celltransplantation (Allo-HSCT);

13. The cumulative dose of anthracyclines > 360 mg/m2 in previous (new) adjuvanttherapy;

14. Human immunodeficiency virus antibody positive, active tuberculosis, activehepatitis B virus infection or active hepatitis C virus infection;

15. Severe infection occurred within 4 weeks before the first dose; Signs of pulmonaryinfection or active pulmonary inflammation within 2 weeks before the first dose;

16. Patients with massive or symptomatic effusions or poorly controlled effusions;

17. Had participated in another clinical trial within 4 weeks before the first dose;

18. Had the following ocular diseases: a. active infection or corneal ulcer; b.monocular vision; c. a history of corneal transplantation; d. Contact lensdependence; e. Uncontrolled glaucoma; f. Uncontrolled or progressive retinopathy,wet macular degeneration, etc.;

19. Other circumstances that the investigator deemed inappropriate for participation inthe trial.