A Study of HB0025 Plus Nab-paclitaxel as First Line Therapy for TNBC

Enrolling by invitation · Phase 2

Conditions studied: TNBC

In brief

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).

Key facts

Study ID

NCT07376629

Run by

Huabo Biopharm Co., Ltd.

People needed

60

Starts

2025-08-14

Expected to finish

2027-01-15

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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 City, 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

Full record on ClinicalTrials.gov

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