A Study of Penpulimab Combination Therapy in Patients With Advanced Nasopharyngeal Carcinoma

Inclusion Criteria:

• Signed written informed consent form voluntarily.

• Age over 18 years old (inclusive) and not more than 75 years old (inclusive), whensigning the ICF.

• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.

• Expected life expectance ≥ 3 months.

• Histologically confirmed diagnosis of stage IVb NPC (AJCC 8th).

• Metastatic NPC patients who have not recieved the first-line platinumbasedchemotherapy.

• At least one measurable tumor lesion per RECIST 1.1 criteria.

• Subjects must provide an available tumor tissue sample taken within 3 years prior toenrollment.

• Adequate organ function.

• Females of childbearing potential who are sexually active with a nonsterilized malepartner must use at least one highly effective method of contraception.

• Nonsterilized males who are sexually active with a female partner of childbearingpotential must use highly effective method of contraception from Day 1 and for 120days after the last dose of investigational product.

Exclusion Criteria:

• Other invasive malignancies within 2 years, except for locally treatable (manifestedas cured) malignancies, such as basal or skin squamous cell carcinoma, superficialbladder cancer, cervical or breast carcinoma in situ.

• Is currently participating in a study of an investigational agent or using aninvestigational device.

• Has known active central nervous system (CNS) metastases.

• Has an active autoimmune disease that has required systemic treatment in the past 2years (i.e. with use of disease modifying agents, corticosteroids orimmunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin orphysiologic corticosteroid replacement therapy for adrenal or pituitaryinsufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjectswith vitiligo or resolved childhood asthma/atopy would be an exception to this rule.Subjects that require intermittent use of bronchodilators or local steroidinjections would not be excluded from the study.

• Has an active infection requiring systemic therapy.

• Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).

• History of myocardial infarction, unstable angina, cardiac or other vascularstenting, angioplasty, or surgery within 12 months prior to day 1 of studytreatment.

• Has undergone major surgery within 30 days of Study Day 1.

• Has received a live virus vaccine within 30 days of the planned first dose of studytherapy.

• Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the study.

• Is pregnant, breastfeeding, or expecting to conceive or father a child within theprojected duration of the study including 120 days following the last dose of studytreatment.

• Has a history or current evidence of any condition, therapy, or laboratoryabnormality that might confound the results of the study, interfere with thesubject's participation for the full duration of the study, or is not in the bestinterest of this subject to participate, in the opinion of the treatinginvestigator.