KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
1 other identifier
interventional
59
0 countries
N/A
Brief Summary
This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedJuly 26, 2019
July 1, 2019
1.3 years
July 25, 2019
July 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response
To estimate the overall response rate (CR + PR) of KN035 in combination with trastuzumab and docetaxel in patients with recurrent or metastatic HER2-positive breast cancer. • Overall Response rate will include confirmed complete response (CR) + confirmed partial response (PR), as determined as per RECIST v1.1 criteria and assessed by the local investigator
12 months
Secondary Outcomes (1)
Adverse events
12 months
Other Outcomes (1)
Disease control rate
12 months
Study Arms (1)
KN035 in combination with trastuzumab and docetaxel
EXPERIMENTALInterventions
8 mg/kg IV loading followed by 6 mg/kg Q3W IV
Eligibility Criteria
You may qualify if:
- Written informed consent
- 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
You may not qualify if:
- History of exposure to the cumulative doses of doxorubicin \> 400 mg / m2 or equivalent
- History of autoimmune diseases
- Active brain metastasis
- Concurrent diseases that compromise patient's safety
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 25, 2019
First Posted
July 26, 2019
Study Start
September 1, 2019
Primary Completion
January 1, 2021
Study Completion
January 1, 2022
Last Updated
July 26, 2019
Record last verified: 2019-07