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Enrolling by Invitation

NCT Number: NCT07376629

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

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).

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Key information

Conditions

TNBC

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anyang Cancer Hospital, Anyang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

HB0025 20 mg/kg plus nab-paclitaxel

Drug

HB0025 20 mg/kg

HB0025 10 mg/kg plus nab-paclitaxel

Drug

HB0025 10 mg/kg

Primary outcomes

  1. 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.

Secondary outcomes

  1. ORR per RECIST 1.1 for Part B

    Time frame: Week 3

    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.

Sponsors and collaborators

Lead sponsor

Huabo Biopharm Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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