A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocolrequirements;

2. No gender restrictions;

3. Age: ≥18 years and ≤75 years;

4. Expected survival time ≥3 months;

5. Patients with unresectable locally advanced or metastaticHER2-positive/low-expressing urological and digestive system tumors, as well asother solid tumors;

6. Agree to provide archived tumor tissue specimens or fresh tissue samples fromprimary or metastatic lesions within the past 2 years;

7. Must have at least one measurable lesion as defined by RECIST v1.1;

8. ECOG performance status score of 0 or 1;

9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined byNCI-CTCAE v5.0;

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

11. Organ function levels must meet the requirements;

12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activatedpartial thromboplastin time (APTT) ≤1.5 × ULN;

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

14. Albumin ≥30 g/L;

15. For premenopausal women with childbearing potential, a pregnancy test (serum/urine)must be performed within 7 days before starting treatment, and the result must benegative; they must not be breastfeeding. All enrolled patients (regardless ofgender) must use adequate barrier contraception throughout the treatment period andfor 7 months after treatment ends.

Exclusion Criteria:

1. Received chemotherapy, biological therapy, immunotherapy, or other antitumortreatments within 4 weeks or 5 half-lives prior to the first dose;

2. Previously treated with ADC drugs containing camptothecin derivatives as payloads;

3. History of severe cardiovascular or cerebrovascular diseases;

4. Active autoimmune or inflammatory diseases;

5. History of other malignancies within 5 years prior to the first dose;

6. Thrombotic events requiring therapeutic intervention within 6 months beforescreening;

7. Patients with significant pleural/peritoneal/pelvic effusion or pericardialeffusion, or those with symptomatic effusion, or poorly controlled effusion;

8. Poorly controlled hypertension despite antihypertensive medication;

9. Current interstitial lung disease, drug-induced interstitial pneumonitis, radiationpneumonitis requiring steroid treatment, or history of these conditions;

10. Patients with primary central nervous system (CNS) tumors or CNS metastases thatfailed local treatment;

11. History of hypersensitivity to recombinant humanized antibodies or human-mousechimeric antibodies, or any excipients of BL-M07D1;

12. Previous organ transplantation or allogeneic hematopoietic stem celltransplantation;

13. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, oractive hepatitis C virus (HCV) infection;

14. Active hepatitis B virus (HBV) infection (exclusion criterion);

15. Severe infection requiring systemic treatment within 4 weeks before the first doseof the study drug;

16. Participation in another clinical trial within 4 weeks before the first dose;

17. Pregnant or lactating women;

18. Any other condition deemed unsuitable for participation in this clinical trial bythe investigator.