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.

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 Overview

• Status: Enrolling by invitation
• Conditions: TNBC
• Intervention / Treatment: Drug: HB0025 20 mg/kg plus nab-paclitaxel; Drug: HB0025 10 mg/kg plus nab-paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anyang, China
    • Anyang Cancer Hospital
  • Changsha, China
    • Xiangya Hospital Central South University
  • Chengdu, China
    • Sichuan Cancer Hospital
  • Fujian, China
    • Fujian Cancer Hospital
  • Guangdong, China
    • Guangdong Provincial People's Hospital
  • Guangzhou, China
    • Sun yat-sen University Cancer Center
  • Hangzhou, China
    • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Harbin, China
    • Harbin Medical University Cancer Hospital
  • Hefei, China
    • Anhui Provincial Hospital
  • Jilin, China
    • The First Hospital of Jilin University
  • Jining, China
    • Affiliated Hospital of Jining Medical University
  • Linyi, China
    • LinYi Cancer Hospital
  • Nanjing, China
    • Jiangsu Province Hospital
  • Shandong, China
    • Shandong Cancer Hospital
  • Shanghai, China
    • Fudan University Shanghai Cancer Center
  • Shanxi, China
    • Shanxi Cancer Hospital
  • Shengyang, China
    • Liaoning Cancer Hospital
  • Suzhou, China
    • The Second Affiliated Hospital of Soochow University
  • Tianjing, China
    • Tianjin Cancer Hospital
  • Wuhan, China
    • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Xi'an, China
    • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Xiamen, China
    • The First Affiliated Hospital of Xiamen University
  • Xuzhou, China
    • Xuzhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HB0025 20mg/kg	Drug: HB0025 20 mg/kg plus nab-paclitaxel; HB0025 20 mg/kg
Experimental: HB0025 10mg/kg	Drug: HB0025 10 mg/kg plus nab-paclitaxel; HB0025 10 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 3

Collaborators and Investigators

• Sponsor: Huabo Biopharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: HB0025-C-0201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: n

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No