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

Phase 2Enrolling By InvitationNCT07376629

Huabo Biopharm Co., Ltd.60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

TNBC

Interventions

HB0025 20 mg/kg plus nab-paclitaxelDRUG

HB0025 20 mg/kg

HB0025 10 mg/kg plus nab-paclitaxelDRUG

HB0025 10 mg/kg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (23)

Anyang Cancer Hospital

Anyang, China

Xiangya Hospital Central South University

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

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.

Time frame: Week 3

Data from ClinicalTrials.gov

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