NCT05985707

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

The Efficacy and Safety of KN026 Combination Chemotherapy ± KN046 in HER2-Positive Advanced Colorectal Cancer and Biliary Tract Cancer as First-Line Treatment： a Phase Ⅱ Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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）.

Conditions

• HER2-positive Colorectal Cancer
• HER2-positive Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	KN026	KN026 is a novel bispecific antibody that simultaneously binds to two distinct HER2 epitopes.
DRUG	KN046	KN046 is a novel bispecific antibody that blocks both PD-L1 interaction with PD-1 and CTLA-4 interaction with CD80/CD86.
DRUG	XELOX	XELOX is the standard first-line chemotherapy in metastatic colorectal cancer and biliary duct cancer.

Timeline

• Start date: 2023-08-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-08-14
• Last updated: 2023-08-21

Locations

1 site across 1 country: China