Phase III Study Comparing YL201 to Chemotherapy in Adults with Recurrent or Metastatic Nasopharyngeal Carcinoma After Prior PD-L1 Inhibitor and Two Chemotherapy Treatments

What this Trial Is About

Researchers are evaluating the safety and effectiveness of YL201 compared to the investigators choice of chemotherapy in adults with recurrent or metastatic nasopharyngeal carcinoma who have previously been treated with PD-L1 inhibitors and at least two chemotherapy regimens. The study aims to see if YL201 can improve overall survival and increase tumor response rates, while also exploring its safety profile, drug behavior in the body, immune response, and the relationship between a specific tumor marker B7-H3 and treatment outcomes. Participants are randomly assigned to one of two treatment groups. One group receives YL201 intravenously on the first day of every 3-week cycle at a recommended dose, continuing until the cancer worsens, side effects become unacceptable, or the participant chooses to stop. The other group receives one of three chemotherapy drugsdocetaxel, capecitabine, or gemcitabineadministered according to standard dosing schedules every 3 weeks, also until disease progression, unacceptable side effects, or withdrawal. During the study, participants undergo regular evaluations including tumor scans assessed by independent reviewers and investigators to measure response rates and survival. Safety is monitored by tracking side effects, and blood samples are collected to study drug levels and immune responses. Tumor tissue is examined to measure B7-H3 expression. The main outcomes, such as tumor response and survival, are expected to be assessed approximately within 36 months, with continuous monitoring to ensure participant safety and treatment adherence throughout the study.

A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma