KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer

Phase 2

• Conditions: HER2-positive Breast Cancer
• Interventions: Biological: KN035; Biological: Trastuzumab; Drug: Docetaxel

• Registration Number: NCT04034823
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-25
• Study First Posted: 2019-07-26
• Last Update Posted: 2019-07-26
• Study Start: 2019-09-01
• Primary Completion: 2021-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KN035 in combination with trastuzumab and docetaxel	KN035	-
KN035 in combination with trastuzumab and docetaxel	Trastuzumab	-
KN035 in combination with trastuzumab and docetaxel	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
Objective response	12 months	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

Name	Time	Method
Adverse events	12 months	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)