A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer
Launched by JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD · Mar 12, 2019
Trial Information
Current as of June 28, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Signed informed consent;
- • Age of 18 or above;
- • Histology confirmed locally advanced unresectable or metastatic triple-negative breaset cancer;
- • (KN046 monotherapy) failed at least one prior anthracycline and taxane containing systemic treatment, (KN046 plus nab-paclitaxel) systemic treatment naive;
- • Measurable disease at baseline;
- • ECOG 0-1;
- • Adequate organ functions.
- Exclusion Criteria:
- • Untreated active CNS metastasis or leptomeningeal metastasis;
- • Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment;
- • Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
- • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent; History of uncontrolled intercurrent illness; Known severe hypersensitivity reactions to antibody drug.
About Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Jiangsu Alphamab Biopharmaceuticals Co., Ltd. is a leading biotechnology company based in China, specializing in the discovery, development, and commercialization of innovative biopharmaceuticals. With a focus on monoclonal antibodies and other targeted therapies, the company aims to address unmet medical needs across various therapeutic areas, including oncology and autoimmune diseases. Leveraging advanced technology platforms and a robust pipeline, Jiangsu Alphamab is committed to enhancing patient outcomes through cutting-edge research and development, while adhering to the highest standards of quality and regulatory compliance in clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guangzhou, Guangdong, China
Zhengzhou, Henan, China
Xiamen, Fujian, China
Changchun, Jilin, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Changsha, Hunan, China
Shenyang, Liaoning, China
Nantong, Jiangsu, China
Liaocheng, Shandong, China
Beijing, Beijing, China
Zibo, Shandong, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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