Clinical Trial

A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma(PANKU-NPC01)

Active, Not Recruiting Phase 3
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Summary
A phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic nasopharyngeal carcinoma who had failed at least two lines of platinum-based chemotherapy after receiving PD-1/PD-L1 monoclonal antibody as the last line of therapy.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-10-31; most recent amendment 2026-04-15.
Status change: Recruiting → Active, Not Recruiting 2025-06-23
Status change: Not Yet Recruiting → Recruiting 2023-12-08
Trial Details
NCT Number NCT06118333
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Nasopharyngeal Carcinoma
Enrollment 386 participants
Start Date 2023-12-04
Primary Completion 2026-11 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-04-17