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

StatusActive, Not Recruiting
PhasePhase 3
Started2023-12-04
View on ClinicalTrials.gov ↗

Amendment history

2026-04-15
Study Identification, Study Status, Contacts/Locations v8
Study title+13 characters
[...] tients With Recurrent or Metastatic Nasopharyngeal Carcinoma(PANKU-NPC01)
2025-09-27
Study Status v7
Completion date2027-12→2026-11
2025-09-25
Study Status v6
Primary completion date2025-12→2026-11
Completion date2025-12→2027-12
2025-06-23
Recruiting→Active, Not Recruiting Study Status, Study Design, Eligibility, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 368→confirmed 386
Eligibility criteria-2,647 characters
Inclusion Criteria: Voluntarily sign the informed consent form and followcomply the requirements ofwith the protocol. No gender limit.requirements; Age ≥18 years old.and ≤75 years; expectedExpected survival time ≥3 months.; Patients with histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma treatedconfirmed by histology or cytology, who have failed treatment with PD-1/PD-L1 monoclonal antibodyantibodies after failure ofand at least two lines of chemotherapy (including at least one line of platinum-based regimen).; Patients whowith arerecurrent or metastatic [...] [...]
Study sitesdetails revised at 1 of 1 site
2025-04-30
2 amendments v3-v4
2 re-verifications since 2024-07-16, no change to tracked fields
Show 2 earlier versions
2024-01-29
Study Status, Sponsor/Collaborators v2
Collaborators+44 characters
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
2023-12-08
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2023-12-04
Study sitesdetails revised at 1 of 1 site
2023-10-31
Original filing
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.
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