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.
1 other identifier
interventional
60
1 country
23
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2025
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2025
CompletedFirst Submitted
Initial submission to the registry
January 13, 2026
CompletedFirst Posted
Study publicly available on registry
January 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 15, 2027
January 29, 2026
January 1, 2026
1.4 years
January 13, 2026
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
Secondary Outcomes (1)
ORR per RECIST 1.1 for Part B
Week 3
Study Arms (2)
HB0025 20mg/kg
EXPERIMENTALHB0025 10mg/kg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug;
- Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF;
- Uncontrollable or symptomatic central nervous system (CNS) metastasis;
- Pregnancy or lactation;
- Those who have active infection
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Anyang Cancer Hospital
Anyang, China
Xiangya Hospital Central South University
Changsha, China
Sichuan Cancer Hospital
Chengdu, China
Fujian Cancer Hospital
Fujian, China
Guangdong Provincial People's Hospital
Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Provincial Hospital
Hefei, China
The First Hospital of Jilin University
Jilin, China
Affiliated Hospital of Jining Medical University
Jining, China
Linyi Cancer Hospital
Linyi, China
Jiangsu Province Hospital
Nanjing, China
Shandong Cancer Hospital
Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shanxi Cancer Hospital
Shanxi, China
Liaoning Cancer Hospital
Shengyang, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
Tianjin Cancer Hospital
Tianjing, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Xuzhou Central Hospital
Xuzhou, China
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2026
First Posted
January 29, 2026
Study Start
August 14, 2025
Primary Completion (Estimated)
January 15, 2027
Study Completion (Estimated)
January 15, 2027
Last Updated
January 29, 2026
Record last verified: 2026-01