A Phase III Randomized Controlled Trial 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 at Least Two Lines of Chemotherapy (at Least One Line of Platinum-based Chemotherapy)

NCT06118333 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Sichuan Baili Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	386
Start date	2023-12-04
Completion	2026-11

Conditions

• Nasopharyngeal Carcinoma

Interventions

• BL-B01D1
• capecitabine
• gemcitabine
• docetaxel

Primary outcomes

• Objective Response Rate (ORR) — Up to approximately 24 months
  Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
• Overall survival (OS) — Up to approximately 24 months
  Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

Countries

China