A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Inclusion Criteria: * Voluntarily signed written Informed Consent Form(ICF). * Main study: Age of ≥ 18 years and ≤ 75 years at the time of enrollment. * Substudy: Age of ≥ 12 years and \< 18 years. Weight≥ 35KG. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Expected survival of ≥ 3 months. * Histologically or cytologically confirmed nasopharyngeal carcinoma. * Subjects with primary metastatic (nasopharyngeal carcinoma, stage IVB defined by the Union for International Cancer Control and the American Joint Committee on Cancer Staging System edition 8) nasopharyngeal carcinoma who are not suitable for local treatment or radical treatment; subjects who have a local-regional recurrence and/or distant metastasis more than 6 months after the completion of prior radical treatment (radiotherapy with induction, concurrent, adjuvant chemotherapy)； No systemic treatment has been received for recurrent or metastatic diseases, not amendable to local treatment or have received local treatment for the local-regional recurrent disease * At least one measurable lesion according to RECIST v1.1; * Has adequate organ function. * All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 150 days after the last dose of study treatment. Exclusion Criteria: * Subjects with pathologically diagnosed nasopharyngeal adenocarcinoma or sarcoma. * Subjects have had another …