This is a multicenter, open-label, Phase II clinical study to assess the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with recurrent or metastatic HNSCC.
Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.
Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is not curable by local therapy and not amenable to curative surgery, with the primary tumor located in the oral cavity, oropharynx, hypopharynx, or larynx.
Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.
History or current metastases to central nervous system.
Subjects with other malignant tumors within 3 years prior to the first dose.
Presence of any cardiovascular and cerebrovascular disorders or risk factors.
Presence of uncontrolled systemic disease.