Status:
COMPLETED
A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer
Lead Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Conditions:
Triple-negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, phase Ib/II, multi-center study to evaluate efficacy and safety of KN046 alone or in combination with nab-paclitaxel in subjects with locally advanced unresectable or metastatic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03872791
Start Date
May 30 2019
End Date
October 27 2022
Last Update
June 8 2023
Active Locations (12)
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1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
2
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
3
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
4
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China