The Efficacy and Safety of HLX07 in Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)

Inclusion Criteria:

1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
2. Aged ≥ 18 years.
3. Histopathologically or cytologically confirmed diagnosis of locally advanced or metastatic Cutaneous Squamous Cell Carcinoma (CSCC).
4. Measurable lesion according to RECIST v1.1 by IRRC.
5. ECOG score 0-1.
6. Expected survival 12 weeks.
7. For fertile female subjects, the pregnancy test must be negative within 7 days before the first dose.

Exclusion Criteria:

1. Prior systemic anti-EGFR monoclonal antibody therapy.
2. A history of other malignancies within three years, except for cured cervical carcinoma in situ, adenocarcinoma in situ of the breast, or tumors that do not require interventional treatment after radical surgery.
3. Participant has any other histologic type of skin cancer, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, MCC, melanoma.
4. Participants with any prior allogeneic solid organ or bone marrow transplantations.
5. Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
6. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
7. Active clinical severe infection.