NCT06023758

Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC

A Multicenter II Study to Compare KN026 and KN046 Versus Oxaliplatin, Capecitabine Combined KN026 and KN046 in Patients With HER2-positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma.

Detailed description

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, resulting in dual HER2 signaling blockade.KN046 is a PD-L1 - CTLA-4 bispecific antibody. The trial consists of two groups. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W in Group 1. If the statistical hypothesis is not met in Group 1, patients will be enrolled in Group 2. Patients in group 2 will receive KN026+KN046+XELOX.

Conditions

• HER2-positive Locally Advanced Resectable Gastric Cancer

Interventions

Type	Name	Description
DRUG	KN026	KN026：30 mg/kg Q3W
DRUG	KN046	KN046：5 mg/kg Q3W
DRUG	XELOX	Oxaliplatin 130mg/m2 d1，Capecitabine 1000mg/m2 d1-14，Q3W

Timeline

• Start date: 2023-09-22
• Primary completion: 2025-09-01
• Completion: 2026-12-31
• First posted: 2023-09-05
• Last updated: 2024-05-10

Locations

1 site across 1 country: China