A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

Inclusion Criteria:

1. Participants must sign the informed consent form voluntarily and follow the planrequirements.

2. No gender limit.

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

4. Expected survival time ≥ 3 months.

5. Locally advanced or metastatic solid tumor confirmed by histopathology and/orcytology, which are incurable or currently without standard treatment.

6. Agrees to provide archived tumor tissue specimens or fresh tissue samples from theprimary lesion or metastasis within 2 years; If a subject is unable to provide atumor tissue sample, he/she may be enrolled after being evaluated by theinvestigator if other inclusion criteria are met.

7. Participants must have at least one measurable lesion that meets the definition ofRECIST v1.1.

8. Physical fitness score ECOG 0 or 1 point

9. Toxicity of previous antitumor therapy has returned to ≤ level 1 as defined byNCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities considered by theinvestigators, such as elevated ALP, hyperuricemia, and elevated blood glucose;Toxicities with no safety risk, such as hair loss and grade 2 peripheralneurotoxicity, were excluded. Or decreased hemoglobin except ≥90 g/L).

10. No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%

11. The organ function level must meet the following requirements: a) bone marrowfunction: absolute neutrophilic granulocyte count (ANC) ≥1.5×109/L, platelet count ≥90×109/L, hemoglobin ≥90 g/L; b) Liver function: total bilirubin (TBIL≤1.5 ULN),AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN inpatients with liver metastasis; c) Kidney function: creatinine (Cr) ≤1.5 ULN, orcreatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula).

12. Coagulation function: International normalized ratio (INR)≤1.5×ULN, and activatedpartial thromboplastin time (APTT)≤1.5ULN.

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

14. For premenopausal women with childbearing potential, a pregnancy test must be takenwithin 7 days prior to the start of treatment. Serum or urine pregnancy must benegative and must be non-lactating; all participants (regardless of male or female)in the group should be treated throughout the treatment. Adequate barriercontraceptive measures should be taken during the treatment and 6 months after thetreatment.

Exclusion Criteria:

1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, majorsurgery, targeted therapy (including small molecule inhibitor of tyrosine kinase),and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter)prior to the first administration; mitomycin and nitrosoureas treatment within 6weeks prior to the first administration; oral fluorouracil-like drugs such as S-1,capecitabine, or palliative radiotherapy within 2weeks prior to the firstadministration.

2. Participants with history of severe heart disease, such as: symptomatic congestiveheart failure (CHF) ≥ grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, history of transmural myocardial infarction, unstable anginapectoris etc.

3. Participants with prolonged QT interval (male QTc> 450 msec or female QTc> 470msec), complete left bundle branch block, III grade atrioventricular block.

4. Active autoimmune diseases and inflammatory diseases, such as: systemic lupuserythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis,inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for type Idiabetes, hypothyroidism that can be controlled only by alternative treatment, andskin diseases that do not require systemic treatment (such as vitiligo, psoriasis).

5. Other malignant tumors were diagnosed within 5 years prior to the firstadministration with the following exceptions: basal cell carcinoma of the skin,squamous cell carcinoma of the skin and/or carcinoma in situ after radicalresection.

6. Participants with poorly controlled hypertension by two kinds of antihypertensivedrugs (systolic blood pressure>150 mmHg or diastolic blood pressure>100 mmHg).

7. Participants have grade 3 lung disease defined according to NCI-CTCAE v5.0, or ahistory of interstitial lung disease (ILD).

8. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis andpulmonary embolism requiring therapeutic intervention within 6 months prior toscreening; Thrombus formation associated with infusion set is excluded.

9. Symptoms of active central nervous system metastasis. However, patients with stablebrain parenchymal metastases can be enrolled. Stable was defined as: a. Theseizure-free state lasted for > 12 weeks with or without the use of antiepilepticdrugs; b. Glucocorticoid use is not required; c. Consecutive MRI scans (at least 8weeks between scans) showed stable imaging status.

10. Patients with a history of allergy to recombinant humanized antibody or mousechimeric antibody or to any excipients of BL-B01D1.

11. Previous recipients of organ transplantation or allogeneic hematopoietic stem celltransplantation (Allo-HSCT).

12. In previous adjuvant therapy with anthracyclines, the cumulative dose ofanthracyclines was > 360 mg/m2.

13. Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, activehepatitis B virus infection (HBV-DNA copy number > 103 IU/ml) or active hepatitis Cvirus infection (HCV antibody positive and HCV-RNA > lower limit of detection).

14. Active infections requiring systemic treatment, such as severe pneumonia,bacteremia, septicemia, etc.

15. Participated in another clinical trial (calculated from the time of the last dose)within 4 weeks prior to the first dose.

16. The other conditions of participation in this clinical trial were not consideredappropriate by the investigators.