A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Trial Parameters
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Brief Summary
This study is an open, multicenter, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M24D1 in patients with locally advanced or metastatic head and neck squamous cell carcinoma and other solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. Gender unrestricted; 3. Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib); 4. Expected survival time ≥3 months; 5. Patients with locally advanced or metastatic head and neck squamous cell carcinoma and other solid tumors; 6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic foci within the past 3 years; 7. Must have at least one measurable lesion meeting the RECIST v1.1 criteria; 8. ECOG performance status score of 0 or 1; 9. Toxicities from prior antitumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. Organ function levels must meet the requirements; 12. Coagulation function: International Normalized Ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN; 13. Urine protein ≤2+ or ≤1000mg/24h; 14. For p