Recurrent or Metastatic Nasopharyngeal Carcinoma Clinical Trial
Official title:
An Open-Label, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with recurrent metastatic nasopharyngeal carcinoma.
The study consists of two stages. Part A of this study is an open-label, single arm, multicenter Phase IIa clinical study in patients with inoperable, radiotherapy ineligible RM-NPC who have failed (or are intolerable) at least 1 prior line platinum-based systemic chemotherapy and PD-1 (L1) inhibitors. Part B is an open-label, randomized, multicenter Phase IIb study to compare the efficacy and safety of MRG003 versus capecitabine/docetaxel in patients with RM-NPC who have failed at least 2 prior lines of systemic chemotherapy and PD-1 (L1) inhibitors. ;