Clinical trial NCT03872791: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Triple-negative Breast Cancer
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-03-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: IRC assessed objective response
timeFrame: From Day 1 to PD, assessed up to 12 months after last patient last dose
measure: IRC assessed duration of response
timeFrame: From Day 1 to PD, assessed up to 12 months after last patient last dose
Secondary outcomes:
measure: PFS rate at 6 and 12 months
timeFrame: From Day 1 to disease progression (PD) or death from any cause, assessed up to 12 months after last patient last dose
measure: Frequency and severity of treatment emergent adverse events
timeFrame: From Day 1 to 90 days after last dose of KN046, through study completion, an average of 1 year
measure: Percentage of subjects with anti-drug antibodies
timeFrame: Day 1 (pre-dose) to 90 days after last dose of KN046, through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Changchun
country: China
facility: JiLin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Liaocheng
country: China
facility: LiaoCheng People's Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Municipal Hospital
state: Shandong
Study officials:
References: