drugset / Trial / NCT07441460

A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer

NCT07441460

Phase 3 Recruiting 1800 enrolled Shanghai JMT-Bio Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, controlled, open-label, multicenter, Phase Ⅲ clinical study designed to compare the efficacy and safety of KN026 combined with HB1801 and chemotherapy versus trastuzumab combined with pertuzumab and chemotherapy as adjuvant therapy in participants with HER2-positive breast cancer.

Timeline

Start
2026-03-06
Primary completion
2034-08-07
Completion
2035-08-07

Drugs

EvaluationDrugModalityDoseRoute
Subject HB1801 Unknown
Subject KN026 Monoclonal antibody
Comparator Pertuzumab Monoclonal antibody Intravenous
Comparator Trastuzumab Monoclonal antibody Intravenous
Background Carboplatin Small molecule Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Comparator Docetaxel Small molecule Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Epirubicin Small molecule Intravenous