A Phase II Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Locally Advanced HER2-positive Breast Cancer

KN026-205

This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The subjects will receive 20 mg/kg IV Q2W+ palbociclib 100/125 mg/day orally+/-Fulvestrant 500 mg IM until progressive disease, unacceptable toxicity or death.

2022-05-25

2023-03-15

2023-03-15

Terminated

4

Inclusion Criteria: * Male or female subject \>= 18 years; * Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive; * Adequate organ function assessed within 7 days prior to first trial treatment * ECOG score 0 or 1; * Left ventricular ejection fraction (LVEF) ≥ 50% at baseline; * Life expectancy \>3 months Exclusion Criteria: * Untreated active CNS metastasis or leptomeningeal metastasis; * Uncontrolled tumor-related pain; * Has received other anti-tumor treatment or an investigational drug within 28 days or within 5 times of half-life (whichever is shorter, and no less than 2 weeks) prior to the first trial treatment; * Major surgery for any reason within 28 days; * Curative radiation within 3 months of the first dose of trial treatment; * History of uncontrolled intercurrent illness; * Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'ctDNA and single cell sequencing analysis may be performed using plasma samples collected from subjects at baseline and upon disease progression.'}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

2023-07-17