The study is to explore the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic Nasopharyngeal Carcinoma (NPC) who failed or are intolerant to second-line herapy.
Fully understand the study content, procedures, and potential adverse reactions before the trial, sign the informed consent form (ICF), voluntarily participate in the trial, and be able to complete the study per the protocol requirements;
Age ≥ 18 years at the time of signing the ICF, regardless of gender;
Histologically or cytologically confirmed recurrent/metastatic nasopharyngeal carcinoma;
Recurrent/metastatic nasopharyngeal carcinoma patients who have failed or are intolerant to at least two prior lines of chemotherapy (including at least one platinum-based regimen) and PD-1/PD-L1 inhibitor therapy. Intolerance is defined as experiencing CTCAE ≥ grade 3 adverse events;
Recurrent nasopharyngeal carcinoma candidates eligible for curative local therapy (surgery or radiotherapy).
Imaging showing tumor invasion/encasement of major thoracic/cervical/pharyngeal blood vessels (may be exempted if investigators confirm no impact on trial participation).
History of other malignancies within 2 years prior to randomization (except radically treated early-stage malignancies).
Previous ≥Grade 3 immune-related adverse events during immunotherapy.