A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

Inclusion Criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. No gender limit; 3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib); 4. Expected survival time ≥3 months; 5. Pathologically and/or cytologically confirmed locally advanced or metastatic gastrointestinal tumors and other solid tumors that failed standard treatment; 6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years; 7. Must have at least one measurable lesion according to RECIST v1.1 definition; 8. ECOG 0 or 1; 9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. Organ function level must meet the requirements; 12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN; 13. Urine protein ≤2+ or ≤1000mg/24h; 14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All enrolled patients (regardless of male or female) should use adequate barrier contraception during the whole treatment cycle and for 6 months after the end of treatment; 15. Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. Exclusion Criteria: 1. Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil; 2. History of severe heart disease; 3. QT prolongation, complete left bundle branch block, III degree atrioventricular block; 4. Active autoimmune and inflammatory diseases; 5. Other malignant tumors diagnosed within 5 years before the first dose; 6. Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose; 7. Poorly controlled hypertension; 8. Patients with poor glycemic control; 9. History of ILD requiring steroid therapy, or current ILD or ≥ grade 2 radiation pneumonitis; 10. Complicated pulmonary diseases leading to clinically severe respiratory function impairment; 11. Symptoms of active central nervous system metastasis; 12. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M09D1; 13. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 14. Anthracycline cumulative dose \> 360 mg/m2 in previous (new) adjuvant therapy; 15. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 16. Active infection requiring systemic therapy within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose; 17. Pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug; 18. Use of another clinical trial within 4 weeks or 5 half-lives before the first dose; 19. Pregnant or lactating women; 20. Other conditions for participation in the trial were not considered appropriate by the investigator.