KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
NCT ID: NCT04034823
Last Updated: 2019-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
59 participants
INTERVENTIONAL
2019-09-01
2022-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KN035 in combination with trastuzumab and docetaxel
KN035
KN035 5 mg/kg s.c. Q3W
Trastuzumab
8 mg/kg IV loading followed by 6 mg/kg Q3W IV
Docetaxel
100 mg/m2 Q3W IV
Interventions
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KN035
KN035 5 mg/kg s.c. Q3W
Trastuzumab
8 mg/kg IV loading followed by 6 mg/kg Q3W IV
Docetaxel
100 mg/m2 Q3W IV
Eligibility Criteria
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Inclusion Criteria
* Female subjects with age 18 to 70 (inclusive) years at the time of consent
* LVEF ≥50% at baseline
* ECOG performance status of 0-1
* Have not received 1L treatment for recurrent or metastatic breast cancer
* Adequate organ function
Exclusion Criteria
* History of autoimmune diseases
* Active brain metastasis
* Concurrent diseases that compromise patient's safety
18 Years
70 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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JZhao
Doctor
Other Identifiers
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KN035-TH-HER2
Identifier Type: -
Identifier Source: org_study_id
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