Clinical trial · Interventional
A Study of HB0025 Plus Nab-paclitaxel as First Line Therapy for TNBC
A Phase II Study of HB0025 in Combination With Nab-Paclitaxel as First Line Therapy for Unresectable, Locally Advanced or Metastatic Triple-negative Breast Cancer.
NCT07376629CI-TRIAL-00102013enrolling by invitationPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| TNBC | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HB0025 10 mg/kg plus nab-paclitaxel | Drug | — | UNRESOLVED |
| HB0025 20 mg/kg plus nab-paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HB0025 20mg/kg
- interventionNames
- Drug: HB0025 20 mg/kg plus nab-paclitaxel
- type
- EXPERIMENTAL
- label
- HB0025 10mg/kg
- interventionNames
- Drug: HB0025 10 mg/kg plus nab-paclitaxel
Primary outcomes (1)
- measure
- The safety and tolerability measures: Incidence,correlation, and severity of adverse events graded according to NCI CTCAE v5.0.
- timeFrame
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent form 2. Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) 3. No prior systemic therapy for inoperable locally advanced or metastatic TNBC 4. ECOG performance status of 0 or 1 5. Life expectancy ≥ 12 weeks 6. Measurable disease, as defined by RECIST v1.1 Exclusion Criteria: 1. History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug; 2. Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF; 3. Uncontrollable or symptomatic central nervous system (CNS) metastasis; 4. Pregnancy or lactation; 5. Those who have active infection 6. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
References
Publications (0)
Data not yet available
No reference posted for this study.