Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.

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

Details

• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Male or female subject >= 18 years

• Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer

• ECOG score 0 or 1

• Life expectancy >3 months

• According to the definition of RECIST1.1, the patient has at least one measurable lesion

• Adequate organ function prior to start treatment with KN026

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

Exclusion Criteria:

• Accepted any other anti-tumor drug therapies within 4 weeks before fist dose

• Accepted radiotherapy within 4 weeks before enrollment

• Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible

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

• History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation

• History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation

• Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage