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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)

Name: 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) — clinical trial record (NCT07783321)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 3

SponsorSichuan Baili Pharmaceutical Co., Ltd.

Started2026-09

View on ClinicalTrials.gov ↗

Amendment history

2026-09-16

Interventions modified

2026-08-25

Study Status, Contacts/Locations v1

Study sitescontacts updated at 1 of 1 site

2026-08-20

Original filing

Sichuan Baili Pharmaceutical Co., Ltd.

135 trials monitored

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Head & Neck Cancer

2,051 trials monitored

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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.

Trial Details

NCT Number	NCT07783321
Lead Sponsor	Sichuan Baili Pharmaceutical Co., Ltd. Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions	Nasopharyngeal Carcinoma (NPC)
Enrollment	404 participants
Start Date	2026-09
Primary Completion	2033-12 (estimated)
Study Completion	2033-12 (estimated)
Updated on ClinicalTrials.gov	2026-09-15