Becotatug Vedotin Plus Gemcitabine and a PD-1 Inhibitor in Recurrent or Metastatic Nasopharyngeal Carcinoma

This is a single-center, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of becotatug vedotin combined with gemcitabine and a PD-1 inhibitor as second-line or later treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have experienced treatment failure following prior platinum-based chemotherapy or PD-(L)1 inhibitor therapy. Patients with recurrent or metastatic NPC who are unsuitable for curative local treatment and meet the eligibility criteria will receive becotatug vedotin, gemcitabine, and a PD-1 inhibitor every 3 weeks for 4-6 cycles, followed by PD-1 inhibitor maintenance therapy until disease progression or unacceptable toxicity. Approximately 30 patients will be enrolled. The primary objective is to evaluate the objective response rate (ORR) according to RECIST version 1.1. Secondary objectives include evaluating disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and treatment safety. This study aims to explore a potential treatment option for patients with recurrent or metastatic NPC who have limited therapeutic options after failure of previous systemic therapy.