A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer
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
1 other identifier
interventional
52
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2019
Typical duration for phase_1
12 active sites
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
March 7, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedStudy Start
First participant enrolled
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2022
CompletedJune 8, 2023
June 1, 2023
3.2 years
March 7, 2019
June 7, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
From Day 1 to PD, assessed up to 12 months after last patient last dose
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
From Day 1 to PD, assessed up to 12 months after last patient last dose
Secondary Outcomes (3)
PFS rate at 6 and 12 months
From Day 1 to disease progression (PD) or death from any cause, assessed up to 12 months after last patient last dose
Frequency and severity of treatment emergent adverse events
From Day 1 to 90 days after last dose of KN046, through study completion, an average of 1 year
Percentage of subjects with anti-drug antibodies
Day 1 (pre-dose) to 90 days after last dose of KN046, through study completion, an average of 1 year
Study Arms (2)
KN046
EXPERIMENTALSubjects 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
KN046 plus nab-paclitaxel
EXPERIMENTALSubjects 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
Interventions
KN046 at a dose level of 3 or 5 mg/kg via intravenous infusion on Days 1 and 15 of 28-day cycle
Nab-paclitaxel at dose level of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of 28-day cycle
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
JiLin Cancer Hospital
Changchun, Jilin, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
LiaoCheng People's Hospital
Liaocheng, Shandong, China
Zibo Municipal Hospital
Zibo, Shandong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2019
First Posted
March 13, 2019
Study Start
May 30, 2019
Primary Completion
August 16, 2022
Study Completion
October 27, 2022
Last Updated
June 8, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 6 months after publication
- Access Criteria
- Health care professionals or researches may raise request to Sponsor to have access to study report, sub-group analysis
all IPD that underlie results in a publication