RecruitingPhase 2NCT06023758

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.


Sponsor

Peking University

Enrollment

18 participants

Start Date

Sep 22, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two targeted antibody therapies (KN026 and KN046) with or without chemotherapy (XELOX) for people with HER2-positive stomach cancer or cancer of the gastroesophageal junction (where the esophagus meets the stomach) that is locally advanced but has not spread to distant organs. HER2-positive means the cancer cells have too many copies of a protein that helps cancer grow. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed locally advanced HER2-positive stomach or gastroesophageal junction cancer - Your heart is functioning well (ejection fraction of 50% or higher) - Your blood counts, kidney, and liver levels are within acceptable ranges - You have a life expectancy of more than 3 months **You may NOT be eligible if...** - You have had another active cancer in the past 5 years - You have HIV infection, active tuberculosis, or lung disease - You have a serious heart condition (e.g., recent heart attack or severe heart failure) - You have previously received immunotherapy drugs like PD-1 or CTLA-4 inhibitors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKN026

KN026:30 mg/kg Q3W

DRUGKN046

KN046:5 mg/kg Q3W

DRUGXELOX

Oxaliplatin 130mg/m2 d1,Capecitabine 1000mg/m2 d1-14,Q3W


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06023758