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

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• No gender restrictions;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Patients with unresectable locally advanced or metastatic HER2-positive/low-expressing urological and digestive system tumors, as well as other solid tumors;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 2 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
• Organ function levels must meet the requirements;
• Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
• Urine protein ≤2+ or ≤1000 mg/24h;
• Albumin ≥30 g/L;
• For premenopausal women with childbearing potential, a pregnancy test (serum/urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 7 months after treatment ends.

Exclusion criteria

• Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose;
• Previously treated with ADC drugs containing camptothecin derivatives as payloads;
• History of severe cardiovascular or cerebrovascular diseases;
• Active autoimmune or inflammatory diseases;
• History of other malignancies within 5 years prior to the first dose;
• Thrombotic events requiring therapeutic intervention within 6 months before screening;
• Patients with significant pleural/peritoneal/pelvic effusion or pericardial effusion, or those with symptomatic effusion, or poorly controlled effusion;
• Poorly controlled hypertension despite antihypertensive medication;
• Current interstitial lung disease, drug-induced interstitial pneumonitis, radiation pneumonitis requiring steroid treatment, or history of these conditions;
• Patients with primary central nervous system (CNS) tumors or CNS metastases that failed local treatment;
• History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-M07D1;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, or active hepatitis C virus (HCV) infection;
• Active hepatitis B virus (HBV) infection (exclusion criterion);
• Severe infection requiring systemic treatment within 4 weeks before the first dose of the study drug;
• Participation in another clinical trial within 4 weeks before the first dose;
• Pregnant or lactating women;
• Any other condition deemed unsuitable for participation in this clinical trial by the investigator.