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NOT YET RECRUITING
NCT07783321
PHASE3

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)

Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase III Randomized Controlled Clinical 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

414

Start Date

2026-09

Completion Date

2033-12

Last Updated

2026-08-26

Healthy Volunteers

No

Interventions

DRUG

BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

PD-1 monoclonal antibody

Administration by intravenous infusion for a cycle of 3 weeks.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China