A Study of BL-M08D1 in Patients With Recurrent or Metastatic Gynecological Malignancies and Other Solid Tumors

Inclusion criteria

• Voluntarily sign the informed consent form and agree to follow the protocol requirements;
• Female;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Recurrent or metastatic gynecological malignancies and other solid tumors;
• Agree to provide archived tumor tissue specimens from the primary or metastatic site within 3 years, or fresh tissue samples;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
• Organ function levels must meet the required criteria;
• Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;
• Urine protein ≤2+ or ≤1000 mg/24h;
• For premenopausal women of childbearing potential, a serum pregnancy test must be negative within 7 days before starting treatment, and they must not be breastfeeding; all enrolled patients must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion;
• The trial participant is capable and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures as specified in the protocol.

Exclusion criteria

• Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
• History of severe heart disease or cerebrovascular disease within 6 months before screening;
• Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;
• Active autoimmune diseases and inflammatory diseases;
• Diagnosis of another malignancy within 5 years prior to the first dose;
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
• Hypertension inadequately controlled by antihypertensive medication;
• Poorly controlled blood glucose;
• History of interstitial lung disease requiring corticosteroid therapy, or currently having ILD or grade ≥2 radiation pneumonitis;
• Severe impairment of respiratory function;
• Active central nervous system metastases;
• History of or coexisting central nervous system lesions;
• History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Active infection requiring systemic therapy within 4 weeks prior to the first dose of the study drug;
• Pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first dose of the study drug;
• Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, or other regions;
• Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;
• Pregnant or breastfeeding women;
• Other conditions that, in the investigator's judgment, make the patient unsuitable for participation in this clinical trial.