Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, phase II，multi-center study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 in subjects with HER2-positive solid tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Collaborator: Peking University

Criteria

Inclusion Criteria:

• Male or female subject >= 18 years;

• Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive solid tumors;

• ECOG score 0 or 1;

• Life expectancy >3 months;

• Baseline measurable disease according to RECIST 1.1 as determined by the local site investigator/radiology assessment;

• Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO (preferred) or MUGA;

• Able to understand, voluntarily participate and willing to sign the ICF.

Exclusion Criteria:

• Untreated active brain metastasis or leptomeningeal metastasis;

• History of Left ventricular ejection fraction (LVEF) decline to < 45% or absolute decrease for > 15% during the treatment course from prior HER2-targeted therapy;

• Has received other anti-tumor treatment or an investigational drug within 28 days prior to the first trial treatment;

• Major surgery for any reason within 28 days ;

• Prior allo-HSCT or solid organ transplant;

• Pregnant or nursing females;or intend pregnancy within this study period or within 6 months after the end of this study;

• 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.