Back to resultsKN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
Primary Purpose
HER2-positive Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
KN035
Trastuzumab
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for HER2-positive Breast Cancer focused on measuring HER2-positive breast cancer, PD-L1 immune checkpoint
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KN035 in combination with trastuzumab and docetaxel
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Adverse events
To characterize the toxicity of KN035 in combination with trastuzumab and docetaxel as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE)
Full Information
NCT ID
NCT04034823
First Posted
July 25, 2019
Last Updated
July 25, 2019
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT04034823
Brief Title
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
Official Title
KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer
Keywords
HER2-positive breast cancer, PD-L1 immune checkpoint
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KN035 in combination with trastuzumab and docetaxel
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
KN035
Intervention Description
KN035 5 mg/kg s.c. Q3W
Intervention Type
Biological
Intervention Name(s)
Trastuzumab
Intervention Description
8 mg/kg IV loading followed by 6 mg/kg Q3W IV
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
100 mg/m2 Q3W IV
Primary Outcome Measure Information:
Title
Objective response
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse events
Description
To characterize the toxicity of KN035 in combination with trastuzumab and docetaxel as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Disease control rate
Description
To estimate the disease control rate (CR + PR + SD) of KN046 in combination with trastuzumab and docetaxel. Disease control rate will include complete response (CR], partial response (PR), and stable disease (SD), as per RECIST v1.1 criteria
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
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