Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer

Launched by JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD · Mar 1, 2021

Keywords

ClinConnect Summary

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.

Gender

ALL

Eligibility criteria

• 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