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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04034823

Enrollment

Registered

2019-07-26

Start date

2019-09-01

Completion date

2022-01-01

Last updated

2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive Breast Cancer

Keywords

HER2-positive breast cancer, PD-L1 immune checkpoint

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.

Interventions

BIOLOGICALKN035

KN035 5 mg/kg s.c. Q3W

BIOLOGICALTrastuzumab

8 mg/kg IV loading followed by 6 mg/kg Q3W IV

DRUGDocetaxel

100 mg/m2 Q3W IV

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Other

Measure	Time frame	Description
Disease control rate	12 months	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026