Last updated: September 18, 2023
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Overall Status: Active - Not Recruiting
Phase
2
Condition
Breast Cancer
Metastatic Cancer
Treatment
KN026 monotherapy
Concurrent chemotherapy and KN026
KN026 combination
Clinical Study ID
NCT04165993
KN026-201
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female subject >= 18 years
- Histologically/cytologically confirmed, locally advanced unresectable or metastaticbreast cancer
- ECOG score 0 or 1
- Life expectancy >3 months
- According to the definition of RECIST1.1, the patient has at least one measurablelesion
- Adequate organ function prior to start treatment with KN026
- Able to understand, voluntarily participate and willing to sign the ICF
Exclusion
Exclusion Criteria:
- Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
- Accepted radiotherapy within 4 weeks before enrollment
- Subjects are eligible with clinically controlled and stable neurologic function >= 4weeks, which is no evidence of CNS disease progression; Subjects with spinal cordcompression and cancerous meningitis are not eligible
- Pregnant or nursing females;or intend pregnancy within this study period or within 6monthes after the end of this study
- History of immunodeficiency, including HIV positive or other acquired, congenitalimmunodeficiency disease, or a history of organ transplantation
- History of immunodeficiency, including HIV positive or other acquired, congenitalimmunodeficiency disease, or a history of organ transplantation
- Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not wellcontrolled, and need locally treatment or repeated drainage
Study Design
Total Participants: 68
Treatment Group(s): 3
Primary Treatment: KN026 monotherapy
Phase: 2
Study Start date:
December 31, 2019
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
ChinaSite Not Available

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