drugset / Trial / NCT07783321

A Study of Anti-PD-1 Antibody With or Without BL-B01D1 as Maintenance Therapy Following Anti-PD-1 Antibody Plus Chemotherapy for the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (PANKU-NPC02)

NCT07783321 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is a registrational Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of PD-1 monoclonal antibody combined with chemotherapy, followed by maintenance therapy with PD-1 monoclonal antibody with or without BL-B01D1, as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.

Timeline

Start
2026-09
Primary completion
2033-12
Completion
2033-12

Drugs

EvaluationDrugModalityDoseRoute
Subject BL-B01D1 Unknown — Intravenous
Background Cisplatin Other / unclassified — Intravenous
Background Gemcitabine Small molecule — Intravenous