drugset / Trial / NCT05985707

KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma

NCT05985707

Phase 2 Not yet recruiting 80 enrolled Peking University Cancer Hospital & Institute
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this Interventional clinical trial is to learn about the efficacy and safety of KN026 and chemotherapy ± KN046 in HER2-positive metastatic colorectal cancer and biliary tract cancer. Participants will receive standard first-line chemotherapy (capecitabine + oxaliplatin) combined with KN026 (a HER2-targeted bispecific antibody) ± KN046 (a PD-L1/CTLA-4 targeted bispecific antibody).

Timeline

Start
2023-08-15
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ERFONRILIMAB Monoclonal antibody
Subject KN026 Monoclonal antibody
Background Capecitabine Small molecule
Background Oxaliplatin Small molecule

Indications