A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M24D1 for Injection in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
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.
• Voluntarily sign the informed consent form and comply with the protocol requirements;
• Gender unrestricted;
• Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
• Expected survival time ≥3 months;
• Patients with locally advanced or metastatic head and neck squamous cell carcinoma and other solid tumors;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic foci within the past 3 years;
• Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
• ECOG performance status score of 0 or 1;
• Toxicities from prior antitumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
⁃ No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
⁃ Organ function levels must meet the requirements;
⁃ Coagulation function: International Normalized Ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;
⁃ Urine protein ≤2+ or ≤1000mg/24h;
⁃ For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative. Patients must not be lactating. All enrolled patients (regardless of gender) should adopt adequate barrier contraception throughout the treatment cycle and for 6 months after treatment ends.