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

Inclusion criteria:

1. Signed the informed consent voluntarily and agreed to follow the programrequirements 2) Either sex 3) Age: ≥18 years 4) Has a life expectancy of ≥3 months

2. Has histologically documented, incurable, locally advanced or metastaticepithelial origin malignant cancer, priority to include the following tumor types:NSCLC, HER2 - breast cancer, esophageal cancer, SCLC, NPC, and HNSCC 6) Agree toprovide archived tumor samples (tissue block or slides) from primary or metastaticsites within 2 years. In the event that no archival tissue is available a freshtissue biopsy is highly encouraged but not mandatory.

3. Has at least one measurable lesion based on RECIST V1.1 8) Has an EasternCooperative Oncology Group performance status (ECOG PS) 0 to 1 9) Toxicity ofprevious 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 asalopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormonereplacement therapy, etc.) 10) Has no serious cardiac dysfunction, left ventricularejection fraction ≥50% 11) Has adequate organ function before registration, definedas: a) Marrow Function: Absolute neutrophil count (ANC) ≥1.2×109 /L, Platelet count ≥100×109 /L, Hemoglobin (Hb) ≥90 g/L b) Hepatic function: Total bilirubin（TBIL≤1.5ULN, AST and ALT without liver metastasis ≤2.5 ULN, AST and ALT with livermetastasis ≤5.0 ULN c) Renal function: Creatinine clearance ≥50 mL/min (According tothe Cockcroft and Gault equation) 12) Coagulation function: international normalizedratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN 13)Urinary protein ≤2+ or ≤1000mg/24 hours 14) Sexually active fertile subjects andtheir partners must agree to use highly effective methods of contraception duringthe course of the study and for 7 months for females and 4 months for males afterthe last dose of study treatment. An additional contraceptive method, such as abarrier method like a condom is required.

4. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test atscreening and must be nonlactating. Female subjects are considered WOCBP unless oneof the following criteria are met: documented permanent sterilization (hysterectomy,bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausalstatus (defined as 12 months of amenorrhea in a woman >45 years old in the absenceof other biological or physiological causes. In addition, females <55 years old musthave a serum follicle stimulating hormone (fsh) level > 40 mIU/mL to confirmmenopause.

5. For subjects with NSCLC:

a) Evidence of documented EGFR TKI-sensitizing deletion mutation in EGFR Exon 19 (ex19del) or leucin-arginine substitution point mutation in EGFR Exon 21 (ex21L858R), the serine-isoleucine mutation in EGFR Exon 20 (ex20S768I), the leucine-glutamine substitution mutation in Exon 21 (ex21L861Q), or the glycine substitution (with alanine, cysteine, or serine) mutation in Exon 18 (ex18G719X) at or after the time of disease diagnosis and prior to initiation of treatment.

17. For Triple-Negative Breast Cancer (TNBC, HER2-/HR-):

a) Histologically or cytologically confirmed and documented locally advanced, recurrent inoperable or metastatic TNBC

Exclusion criteria:

1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targetedtherapy (including small molecule inhibitor of tyrosine kinase), and otheranti-tumor therapy within 2 weeks or 5 half-lives (whichever is shorter) prior tothe first administration; major surgery within 4 weeks prior to the firstadministration; mitomycin and nitrosoureas treatment within 6 weeks prior to thefirst administration

2. Subjects with history of severe heart disease, such as: symptomatic congestive heartfailure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2heart failure, history of transmural myocardial infarction, unstable angina pectorisetc;

3. Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branchblock, Grade 3 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 standard of care treatment,and skin 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 radical resection

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

7. Subjects have Grade 3 lung disease defined according to NCI-CTCAE v5.0, a history ofinterstitial lung disease (ILD)/ pneumonitis

8. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, andpulmonary embolism requiring therapeutic intervention within the previous 6 monthsbefore screening; Infusion set-related thrombosis is excluded

9. Patients with primary tumors in the central nervous system (CNS) and active oruntreated CNS metastases and/or carcinomatous meningitis should be excluded.Patients with previously treated brain metastases may participate provided they areclinically stable for at least 4 weeks and have no evidence of new or enlargingbrain metastases and no requirements for corticosteroids 14 days prior to dosingwith the investigational product (IP). Patients on low dose corticosteroids (<20 mgprednisone or equivalent/day) may participate.

10. Subjects who have a history of allergies to recombinant humanized antibodies orhuman-mouse chimeric antibodies or any of the components of BL-B01D1

11. Subjects have a history of autologous or allogeneic stem cell transplantation (Allo-HSCT)

12. Has received treatment with anthracyclines with a cumulative dose exceeding 360mg/m2

13. Subjects with ≥ Grade 2 hypokalemia (low concentration of potassium in the blood)according to CTCAE v5.0 (Grade 1: subject asymptomatic with potassium levels <LLN - 3.0 mmol/L or equivalent)

14. Known Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis,active Hepatitis B virus infection (HBV-DNA copy number> the lower limit ofdetection) or active Hepatitis C virus infection (HCV antibody positive and HCV-RNA > the lower limit of detection)

15. Subjects with active infections requiring systemic treatment, such as severepneumonia, bacteremia, sepsis.

16. Received an investigational drug within 4 weeks, or two half-lives (whichever islonger) prior to first dose of study treatment

17. Subjects who are pregnant or breastfeeding

18. Other conditions that the investigator believes may make the subject not suitablefor participating in this clinical trial.

19. For subjects with NSCLC:

20. Prior therapy with any ADC targeting EGFR and/or HER3 or containing atopoisomerase 1 inhibitor payload

21. Participants treated with more than two systemic chemotherapies prior torandomization. NOTE: Progression of disease within 12 months after receivingneoadjuvant and adjuvant chemotherapies is considered 1 prior systemicchemotherapy

22. Previously documented EGFR Exon 20 insertion mutations as primary EGFRmutations

23. For Triple-Negative Breast Cancer (TNBC, HER2-/HR-):

24. Prior therapy with any ADC targeting EGFR and/or HER3 or containing atopoisomerase 1 inhibitor payload Note: For TNBC dose expansion cohort, if fewsubjects without prior ADC therapy targeting HER3 and EGFR or with a topo Iinhibitor can be enrolled, then subjects with prior ADCs with these targets orpayload may be enrolled upon consultation with the sponsor

25. Participants treated with more than two systemic chemotherapies prior torandomization. NOTE: Progression of disease within 12 months after receivingneoadjuvant and adjuvant chemotherapies is considered 1 prior systemicchemotherapy