New drug candidate BL-B01D1 targets Hard-to-Treat cancers in early trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. Age: ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. Histologically and/or cytologically confirmed recurrent or metastatic gynecological malignancies with failed standard treatment, intolerance to standard treatment, or no current standard treatment available; 5. Agree to provide archived tumor tissue specimens (10 slides) or fresh tissue samples from primary or metastatic lesions within the past 3 years; 6. Must have at least one measurable lesion as defined by RECIST v1.1; 7. ECOG performance status score of 0 or 1; 8. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; 9. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%; 10. Organ function levels must meet the requirements without transfusion, albumin, colony-stimulating factors, any cell growth factors, and/or platelet-raising drugs within 14 days before the first dose of the study drug; 11. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN; 12. Urine protein ≤2+ or ≤1000 mg/24h; 13. For premenopausal women with childbearing potential, a pregnancy test (serum or urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends. Exclusion Criteria: 1. Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.); 2. History of severe heart disease; 3. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia; 4. Active autoimmune or inflammatory diseases; 5. Other malignancies with progression or requiring treatment within 5 years prior to the first dose; 6. Poorly controlled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg) despite the use of two antihypertensive medications; 7. Poorly controlled blood glucose levels; 8. History of interstitial lung disease (ILD), current ILD, or suspected ILD based on imaging during screening; 9. Concurrent pulmonary disease leading to clinically significant respiratory impairment; 10. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 11. Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases); 12. Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion; 13. History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-B01D1; 14. Imaging findings indicating tumor invasion or encasement of major thoracic, cervical, or pharyngeal blood vessels; 15. Previous 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 for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection; 18. Severe infection within 4 weeks before the first dose of the study drug; signs of active pulmonary infection within 2 weeks before the first dose; 19. Participation in another clinical trial within 4 weeks before the first dose; 20. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.