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NCT06118333

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

A Phase III Randomized Controlled Trial Was Conducted to Compare BL-B01D1 With Physician's Choice of Chemotherapy (Last Line) in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Previously Treated With PD-1/PD-L1 Monoclonal Antibody and Failed to Respond to at Least Two Lines of Chemotherapy (at Least One Line of Platinum-based Chemotherapy)
Sichuan Baili Pharmaceutical Co., Ltd.·Phase 3·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Nasopharyngeal Carcinoma
Drug/Device/Intervention
BL-B01D1
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Location
Guangzhou, China
Timeline & enrollment
Phase
Phase 3
Start date
Nov 01, 2023
End date
Dec 01, 2025
Enrollment
368 participants
Primary outcome

Objective Response Rate (ORR),Overall survival (OS)

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.

ICD-10 classifications
Malignant neoplasm of nasopharynxMalignant neoplasm: Nasopharynx, unspecifiedMalignant neoplasm: Overlapping lesion of nasopharynxBenign neoplasm: NasopharynxMalignant neoplasm: Posterior wall of nasopharynx
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06118333
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06118333 through Pure Global AI's free database. This Phase 3 trial is sponsored by Sichuan Baili Pharmaceutical Co., Ltd. and is currently Not yet recruiting. The study focuses on Nasopharyngeal Carcinoma. Target enrollment is 368 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.