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
Trial Parameters
Brief Summary
This phase II study is designed to investigate the efficacy and safety of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. All subjects voluntarily participated in the study and signed informed consent. 2. Male or female aged ≥18 years and ≤75 years. 3. Expected survival time ≥3 months. 4. ECOG 0-1. 5. Patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) confirmed by histopathology and/or cytology: 1. Cohort\_A, B, and Cohort\_C Stage I patients who had failed or were intolerant to 1 or more lines of systemic therapy for recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma); 2. Cohort\_C Stage II patients who had not received any previous systemic antitumor therapy (other than induction chemotherapy, neoadjuvant, or adjuvant therapy) for recurrent or metastatic HNSCC (non-nasopharyngeal); Treatment failure was defined as disease progression during or after systemic antitumor therapy. Intolerance refers to the refusal of patients to continue the original regimen due to grade 3-4 adverse reactions after receiving standard tre