A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. • ClinicalTrials.gov ID: NCT07729956
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This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.
Interventions
-
BL-B01D1
(Drug)
Administration by intravenous infusion for a cycle of 3 weeks.
-
PD-1 monoclonal antibody
(Drug)
Administration by intravenous infusion for a cycle of 3 weeks.
-
Nab-paclitaxel
(Drug)
Administration by intravenous infusion for a cycle of 3 weeks.
Eligibility criteria
Conditions
Locations
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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