Evaluating BL-M05D1 for advanced solid tumors

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with protocol requirements;
2. No gender restriction;
3. Age: ≥18 years and ≤75 years;
4. Expected survival time ≥3 months;
5. Locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology that have failed or are intolerant to standard treatment, or for which no standard treatment currently exists;
6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years or fresh tissue samples;
7. Must have at least one measurable lesion as defined by RECIST v1.1;
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
9. Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
11. Organ function levels must meet the requirements under the premise that no blood transfusion and no use of any cell growth factors and/or platelet-elevating agents are allowed within 14 days before screening assessments;
12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 ULN;
13. Urine protein ≤2+ or ≤1000 mg/24 h;
14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be breastfeeding; all enrolled patients (whether male or female) must use adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the end of treatment.

Exclusion Criteria:

1. Prior antitumor therapy such as chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives before the first dose; mitomycin and nitrosoureas within 6 weeks before the first dose; oral fluorouracil drugs or palliative radiotherapy within 2 weeks before the first dose; Chinese patent medicines within 2 weeks before the first dose;
2. History of severe cardiovascular or cerebrovascular disease;
3. QT interval prolongation, complete left bundle branch block, grade III atrioventricular block, frequent and uncontrollable arrhythmias;
4. Active autoimmune disease and inflammatory disease;
5. Diagnosis of other malignancies within 5 years before the first dose;
6. Hypertension inadequately controlled with two antihypertensive drugs;
7. History of ILD, or current radiation pneumonitis, or suspected such disease;
8. Pulmonary disease defined as grade ≥2 according to CTCAE v5.0; concurrent pulmonary disease causing clinically severe respiratory impairment;
9. Patients with poorly controlled blood glucose;
10. Patients with active central nervous system metastases;
11. Patients with massive serous cavity effusion, or serous cavity effusion with symptoms, or inadequately controlled serous cavity effusion;
12. Imaging examination indicating that the tumor has invaded or encased major vessels in the chest, neck, pharynx, etc.;
13. History of pulmonary embolism or thrombotic events requiring therapeutic intervention within 6 months before screening; infusion device-related thrombosis excluded;
14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M05D1;
15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
16. Cumulative anthracycline dose \>360 mg/m2 in prior (neo)adjuvant anthracycline therapy;
17. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
18. Active infection requiring systemic treatment;
19. Participation in another clinical trial within 4 weeks before the first dose;
20. Pregnant or breastfeeding women;
21. Esophageal or gastric varices requiring intervention within the past three months or diseases with a high risk of bleeding;
22. History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection, etc.;
23. Other circumstances in which the investigator considers the patient unsuitable for participation in this clinical trial.