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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HB0025 20mg/kg | Experimental |
| |
| HB0025 10mg/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB0025 20 mg/kg plus nab-paclitaxel | Drug | HB0025 20 mg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anyang Cancer Hospital | Anyang | China | ||||
| Xiangya Hospital Central South University |
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| HB0025 10 mg/kg plus nab-paclitaxel |
| Drug |
HB0025 10 mg/kg |
|
| Changsha |
| China |
| Sichuan Cancer Hospital | Chengdu | China |
| Fujian Cancer Hospital | Fujian | China |
| Guangdong Provincial People's Hospital | Guangdong | China |
| Sun Yat-sen University Cancer Center | Guangzhou | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | China |
| Harbin Medical University Cancer Hospital | Harbin | China |
| Anhui Provincial Hospital | Hefei | China |
| The First Hospital of Jilin University | Jilin City | China |
| Affiliated Hospital of Jining Medical University | Jining | China |
| Linyi Cancer Hospital | Linyi | China |
| Jiangsu Province Hospital | Nanjing | China |
| Shandong Cancer Hospital | Shandong | China |
| Fudan University Shanghai Cancer Center | Shanghai | China |
| Shanxi Cancer Hospital | Shanxi | China |
| Liaoning Cancer Hospital | Shengyang | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | China |
| Tianjin Cancer Hospital | Tianjing | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | China |
| Xuzhou Central Hospital | Xuzhou | China |
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
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