NCT07376629Enrolling by invitationPhase 2
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.
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Jan 2026
- Start date
- Aug 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- Huabo Biopharm Co., Ltd.
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07376629
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From Aug 2025 to the primary completion date, Jan 2027
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF;
Other illness
- History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug;
- Those who have active infection
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
Other
- Uncontrollable or symptomatic central nervous system (CNS) metastasis;
- Pregnancy or lactation;
Who the study is looking for
- Signed informed consent form
- Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- No prior systemic therapy for inoperable locally advanced or metastatic TNBC
- ECOG performance status of 0 or 1
- Life expectancy ≥ 12 weeks
- Measurable disease, as defined by RECIST v1.1
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anyang Cancer Hospital Coordinator of this site? Confirm its status | Anyang | China | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fujian | China | Unknown status |
| Guangdong Provincial People'S Hospital Coordinator of this site? Confirm its status | Guangdong | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Jilin City | China | Unknown status |
| Affiliated Hospital of Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Shandong | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanxi Cancer Hospital Coordinator of this site? Confirm its status | Shanxi | China | Unknown status |
| Liaoning Cancer Hospital Coordinator of this site? Confirm its status | Shengyang | China | Unknown status |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Cancer Hospital Coordinator of this site? Confirm its status | Tianjing | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Xuzhou Central Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.