TNBCPhase 2NCT07376629
A Study of HB0025 Plus Nab-paclitaxel as First Line Therapy for TNBC
A Phase 2 study testing HB0025 20 mg/kg plus nab-paclitaxel and HB0025 10 mg/kg plus nab-paclitaxel in people with TNBC, run by Huabo Biopharm Co., Ltd. at 23 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TNBC
- What is being tested?
- HB0025 20 mg/kg plus nab-paclitaxel and HB0025 10 mg/kg plus nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 23 sitesChina
- Study dates
- 14 Aug 2025to 15 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
China23 sites
Anyang Cancer Hospital
Anyang
Xiangya Hospital Central South University
Changsha
Sichuan Cancer Hospital
Chengdu
Fujian Cancer Hospital
Fujian
Guangdong Provincial People's Hospital
Guangdong
Sun Yat-sen University Cancer Center
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
Anhui Provincial Hospital
Hefei
The First Hospital of Jilin University
Jilin City
Affiliated Hospital of Jining Medical University
Jining
Linyi Cancer Hospital
Linyi
Jiangsu Province Hospital
Nanjing
Shandong Cancer Hospital
Shandong
Fudan University Shanghai Cancer Center
Shanghai
Shanxi Cancer Hospital
Shanxi
Liaoning Cancer Hospital
Shengyang
The Second Affiliated Hospital of Soochow University
Suzhou
Tianjin Cancer Hospital
Tianjing
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
The First Affiliated Hospital of Xiamen University
Xiamen
Xuzhou Central Hospital
Xuzhou
About this study
Official title: 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.
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
- TNBC
- Being tested
- HB0025 20 mg/kg plus nab-paclitaxel, HB0025 10 mg/kg plus nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0025 20 mg/kg plus nab-paclitaxelDrug
HB0025 20 mg/kg
HB0025 10 mg/kg plus nab-paclitaxelDrug
HB0025 10 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| HB0025 20mg/kg | Experimental | Not described Receives: Drug: HB0025 20 mg/kg plus nab-paclitaxel |
| HB0025 10mg/kg | Experimental | Not described Receives: Drug: HB0025 10 mg/kg plus nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start14 Aug 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huabo Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376629
- Sponsor's protocol ID
- HB0025-C-0201
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: n
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07376629
- Acronym / sponsor ID
- HB0025-C-0201
- Conditions
- TNBC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huabo Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HB0025 20mg/kg | Experimental | Drug: HB0025 20 mg/kg plus nab-paclitaxel |
| HB0025 10mg/kg | Experimental | Drug: HB0025 10 mg/kg plus nab-paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB0025 20 mg/kg plus nab-paclitaxelHB0025 20 mg/kg | Drug | HB0025 20mg/kg |
| HB0025 10 mg/kg plus nab-paclitaxelHB0025 10 mg/kg | Drug | HB0025 10mg/kg |
Primary outcome
The safety and tolerability measures: Incidence,correlation, and severity of adverse events graded according to NCI CTCAE v5.0.
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.
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.
1 secondary outcome
ORR per RECIST 1.1 for Part B
Time frame: Week 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided. n
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HB0025 20 mg/kg plus nab-paclitaxel and HB0025 10 mg/kg plus nab-paclitaxel in people with TNBC, run by Huabo Biopharm Co., Ltd. at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability measures: Incidence,correlation, and severity of adverse events graded according to NCI CTCAE v5.0. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.