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.
Single group
SKB571
DrugSKB571
Objective response rate (ORR) of SKB571
ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Progression-free survival (PFS)
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Duration of Response (DOR)
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Disease control rate (DCR)
Assessed by the investigators as per RECIST v1.1
Overall Survival (OS)
Time from start of treatment to death due to any reason.
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