A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Must have received: systemic therapy — recurrent or metastatic

patients who had failed or were intolerant to 1 or more lines of systemic therapy for recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma)

Cannot have received: ADC drug with a topoisomerase I inhibitor as a toxin

Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin

Cannot have received: antineoplastic therapy (chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery, targeted therapy including small-molecule tyrosine kinase inhibitors)

Exception: oral fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks before the first dose

Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors), has been administered within 4 weeks or 5 half-life cycles (whichever is shorter) before the first dose; Oral fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks before the first dose.

Cannot have received: immunomodulatory drugs (thymosin, interleukin-2, interferon)

immunomodulatory drugs (including but not limited to thymosin, interleukin-2, interferon, etc.) within 14 days before the first dose of study drug was excluded

Cannot have received: systemic corticosteroids (prednisone)

Exception: inhaled or topical corticosteroids or physiological replacement doses of corticosteroids for adrenal insufficiency

Systemic corticosteroids (> 10mg/ day of prednisone, or the equivalent of another corticosteroid) are required within 2 weeks before the first dose of the study dose; Exceptions were inhaled or topical corticosteroids or physiological replacement doses of corticosteroids for adrenal insufficiency.