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.

Status

Enrolling by invitation

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07376629

Enrollment

Registered

2026-01-29

Start date

2025-08-14

Completion date

2027-01-15

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TNBC

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).

Interventions

DRUGHB0025 20 mg/kg plus nab-paclitaxel

HB0025 20 mg/kg

DRUGHB0025 10 mg/kg plus nab-paclitaxel

HB0025 10 mg/kg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The safety and tolerability measures: Incidence,correlation, and severity of adverse events graded according to NCI CTCAE v5.0.	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

Measure	Time frame	Description
ORR per RECIST 1.1 for Part B	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026