Back to resultsA Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer
Primary Purpose
Triple-negative Breast Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
KN046
Nab-paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Triple-negative Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- The First Affiliated Hospital of Xiamen University
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Sun Yat-sen University Cancer Center
- Harbin Medical University Cancer Hospital
- Henan Cancer Hospital
- Hunan Cancer Hospital
- Nantong Tumor Hospital
- JiLin Cancer Hospital
- Liaoning Cancer Hospital
- LiaoCheng People's Hospital
- Zibo Municipal Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
KN046
KN046 plus nab-paclitaxel
Arm Description
Subjects will receive KN046 at a dose of 3 mg/kg or 5 mg/kg via intravenous infusion on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity or completion of 2 years of treatment
Subjects will receive KN046 at a dose of 3 mg/kg or 5 mg/kg via intravenous infusion on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity or completion of 2 years of treatment Subjects will receive nab-paclitaxel at a dose of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity
Outcomes
Primary Outcome Measures
IRC assessed objective response
Objective response is defined as complete response (CR) or partial response (PR), as determined by the independent review committee using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD
IRC assessed duration of response
Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions
Secondary Outcome Measures
PFS rate at 6 and 12 months
PFS is defined as the time from Day 1 to the first occurrence of PD, as determined by the independent review committee or investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. PFS rate at 6 and 12 months is defined as percentage of subjects who are alive without progressive disease or death at 6 and 12 months
Frequency and severity of treatment emergent adverse events
Treatment emergent adverse event is defined as those events with onset days occurring during the on-treatment period till 90 days after last dose of KN046 or if the worsening of an event is during the on-treatment period till 90 days after last dose of KN046
Percentage of subjects with anti-drug antibodies
ADA is defined as human anti-drug antibodies
Full Information
NCT ID
NCT03872791
First Posted
March 7, 2019
Last Updated
June 7, 2023
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03872791
Brief Title
A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer
Official Title
A Phase Ib/II Study to Evaluate Efficacy, Safety and Tolerability of KN046 Monotherapy or in Combination With Nab-paclitaxel in Subjects With Triple-negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
August 16, 2022 (Actual)
Study Completion Date
October 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 triple negative breast cancer (TNBC). The study is composed of dose escalation and expansion parts. Every subject will subject tumor tissue used for biomarker evaluation. Each subject will receive KN046 or in combination with nab-paclitaxel untill confirmed progressive disease, unacceptable toxicity or withdrawal of informed consent whichever occurs first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-negative Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KN046
Arm Type
Experimental
Arm Description
Subjects will receive KN046 at a dose of 3 mg/kg or 5 mg/kg via intravenous infusion on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity or completion of 2 years of treatment
Arm Title
KN046 plus nab-paclitaxel
Arm Type
Experimental
Arm Description
Subjects will receive KN046 at a dose of 3 mg/kg or 5 mg/kg via intravenous infusion on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity or completion of 2 years of treatment Subjects will receive nab-paclitaxel at a dose of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity
Intervention Type
Biological
Intervention Name(s)
KN046
Intervention Description
KN046 at a dose level of 3 or 5 mg/kg via intravenous infusion on Days 1 and 15 of 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Nab-paclitaxel at dose level of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of 28-day cycle
Primary Outcome Measure Information:
Title
IRC assessed objective response
Description
Objective response is defined as complete response (CR) or partial response (PR), as determined by the independent review committee using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD
Time Frame
From Day 1 to PD, assessed up to 12 months after last patient last dose
Title
IRC assessed duration of response
Description
Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions
Time Frame
From Day 1 to PD, assessed up to 12 months after last patient last dose
Secondary Outcome Measure Information:
Title
PFS rate at 6 and 12 months
Description
PFS is defined as the time from Day 1 to the first occurrence of PD, as determined by the independent review committee or investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. PFS rate at 6 and 12 months is defined as percentage of subjects who are alive without progressive disease or death at 6 and 12 months
Time Frame
From Day 1 to disease progression (PD) or death from any cause, assessed up to 12 months after last patient last dose
Title
Frequency and severity of treatment emergent adverse events
Description
Treatment emergent adverse event is defined as those events with onset days occurring during the on-treatment period till 90 days after last dose of KN046 or if the worsening of an event is during the on-treatment period till 90 days after last dose of KN046
Time Frame
From Day 1 to 90 days after last dose of KN046, through study completion, an average of 1 year
Title
Percentage of subjects with anti-drug antibodies
Description
ADA is defined as human anti-drug antibodies
Time Frame
Day 1 (pre-dose) to 90 days after last dose of KN046, through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
JiLin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
LiaoCheng People's Hospital
City
Liaocheng
State/Province
Shandong
Country
China
Facility Name
Zibo Municipal Hospital
City
Zibo
State/Province
Shandong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Health care professionals or researches may raise request to Sponsor to have access to study report, sub-group analysis
Learn more about this trial
A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer
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