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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: HER2-positive Breast Cancer

Treatments: Biological: KN035; Drug: Docetaxel; Biological: Trastuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04034823

KN035-TH-HER2

Details and patient eligibility

About

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.

Enrollment: 59 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

KN035 in combination with trastuzumab and docetaxel

Experimental group

Treatment:

Biological: Trastuzumab

Biological: KN035

Drug: Docetaxel