At a glance
ClinicalIndex Comparison RecordPhase 3Active· 386 enrolled
Drug / intervention
BL-B01D1 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating BL-B01D1, capecitabine, and 2 other interventions for Nasopharyngeal Carcinoma. Active but no longer recruiting, targeting 386 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasopharyngeal Carcinoma
CountriesChina
CollaboratorsBaili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Timeline
Phase 3Active
202420252026
First PostedNov 2023
Enrollment StartDec 2023
TodayJul 2026
Primary CompletionNov 2026
First PostedNov 7, 2023
Enrollment StartDec 4, 2023
Primary CompletionNov 1, 2026
TodayJul 1, 2026
Enrollment to primary: 2.9 yearsPosted 2.6 years agoPrimary completion in 4 months
Interventions
BL-B01D1drug
Administration by intravenous infusion
capecitabinedrug
Oral administration
gemcitabinedrug
Administration by intravenous infusion
docetaxeldrug
Administration by intravenous infusion