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

Huabo Biopharm

Status and phase: Invitation-only; Phase 2

Conditions: TNBC

Treatments: Drug: HB0025 20 mg/kg plus nab-paclitaxel; Drug: HB0025 10 mg/kg plus nab-paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT07376629

HB0025-C-0201

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

HB0025 20mg/kg

Experimental group

Treatment:

Drug: HB0025 20 mg/kg plus nab-paclitaxel

HB0025 10mg/kg

Experimental group

Treatment:

Drug: HB0025 10 mg/kg plus nab-paclitaxel