A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer

Triple-negative Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03872791
• Other study ID #: KN046-203
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 30, 2019
• Est. completion date: October 27, 2022

Study information

• Verified date: June 2023
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 27, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer

Intervention

Biological:
• KN046
KN046 at a dose level of 3 or 5 mg/kg via intravenous infusion on Days 1 and 15 of 28-day cycle

Drug:
• Nab-paclitaxel
Nab-paclitaxel at dose level of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of 28-day cycle

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing
China	JiLin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
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	LiaoCheng People's Hospital	Liaocheng	Shandong
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Zibo Municipal Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	From Day 1 to disease progression (PD) or death from any cause, assessed up to 12 months after last patient last dose
Secondary	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	From Day 1 to 90 days after last dose of KN046, through study completion, an average of 1 year
Secondary	Percentage of subjects with anti-drug antibodies	ADA is defined as human anti-drug antibodies	Day 1 (pre-dose) to 90 days after last dose of KN046, through study completion, an average of 1 year