A Study of HB0025 Plus Nab-paclitaxel as First Line Therapy for TNBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HB0025 20 mg/kg plus nab-paclitaxel, HB0025 10 mg/kg plus nab-paclitaxel.
- Who it may be relevant to
- Registry conditions: TNBC. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
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).
Interventions
- Drug HB0025 20 mg/kg plus nab-paclitaxel
HB0025 20 mg/kg - Drug HB0025 10 mg/kg plus nab-paclitaxel
HB0025 10 mg/kg
Primary outcome measures
- 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.]
Secondary outcome measures (1)
- ORR per RECIST 1.1 for Part B [Time frame: Week 3]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 23 centers
- Anyang Cancer Hospital — Anyang
- Xiangya Hospital Central South University — Changsha
- Sichuan Cancer Hospital — Chengdu
- Fujian Cancer Hospital — Fujian
- Guangdong Provincial People's Hospital — Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou
- Harbin Medical University Cancer Hospital — Harbin
- … and 15 more centers
Identifiers
NCT: NCT07376629 · HB0025-C-0201