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

Alphamab

Status and phase: Completed; Phase 2; Phase 1

Conditions: Triple-negative Breast Cancer

Treatments: Biological: KN046; Drug: Nab-paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03872791

KN046-203

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

KN046

Experimental group

Description:

Subjects will receive KN046 at a dose of 3 mg/kg or 5 mg/kg via intravenous infusion on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity or completion of 2 years of treatment

Treatment:

Biological: KN046

KN046 plus nab-paclitaxel

Experimental group

Description:

Subjects will receive KN046 at a dose of 3 mg/kg or 5 mg/kg via intravenous infusion on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity or completion of 2 years of treatment Subjects will receive nab-paclitaxel at a dose of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity

Treatment:

Biological: KN046

Drug: Nab-paclitaxel