A Phase 2 interventional study of HB0025 20 mg/kg plus nab-paclitaxel and HB0025 10 mg/kg plus nab-paclitaxel in TNBC, sponsored by Huabo Biopharm Co., Ltd.. Enrolling by invitation at 23 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Huabo Biopharm Co., Ltd. · Phase 2, Interventional, and Treatment
This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HB0025 administered with chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
Huabo Biopharm Co., Ltd. is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: HB0025 20 mg/kg plus nab-paclitaxel
Drug: HB0025 10 mg/kg plus nab-paclitaxel
HB0025 20 mg/kg
HB0025 10 mg/kg
The safety and tolerability measures: Incidence,correlation, and severity of adverse events graded according to NCI CTCAE v5.0.
Safety profile including adverse events, changes in safety assessment parameters. Incidence, severity, outcome, and correlation to the study drug of all adverse events (AE), treatment-emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESI) assessed according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0; Changes in vital signs, ECOG score, physical examination, electrocardiogram, and laboratory test results before and after study treatment.
Time frame: From first dose to the time of the disease progression, intolerable toxicity, initiation of new antitumor therapy, loss to follow-up, death, withdrawal of study, completion of 2-year treatment of HB0025, or other reasons, whichever comes first.
ORR per RECIST 1.1 for Part B
From first dose to the time of the disease progression, intolerable toxicity, initiation of new antitumor therapy, loss to follow-up, death, withdrawal of study, completion of 2-year treatment of HB0025, or other reasons, whichever comes first.
Time frame: Week 3
Plan to share: Undecided — n
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Huabo Biopharm Co., Ltd.