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

HER2-positive Breast Cancer Clinical Trial

Official title:

KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04034823
• Other study ID #: KN035-TH-HER2
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: July 2019
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 59
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Biological:
• KN035
KN035 5 mg/kg s.c. Q3W
• Trastuzumab
8 mg/kg IV loading followed by 6 mg/kg Q3W IV

Drug:
• Docetaxel
100 mg/m2 Q3W IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease control rate	To estimate the disease control rate (CR + PR + SD) of KN046 in combination with trastuzumab and docetaxel. Disease control rate will include complete response (CR], partial response (PR), and stable disease (SD), as per RECIST v1.1 criteria	12 months
Primary	Objective response	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	12 months
Secondary	Adverse events	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)	12 months