RecruitingPhase 2NCT06196697

AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer

A Phase II, Single Arm, Single Center Study of Cadonilimab(AK104) in Combination With Ivonescimab(AK112) Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced Gastric (G) or Gastroesophageal Junction (GEJ) Cancer

Sponsor

Harbin Medical University

Enrollment

50 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

Gastroesophageal Junction Adenocarcinoma Gastric Adenocarcinoma

Summary

The goal of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and anti-tumor activities of cadonilimab in combination with Ivonescimab plus chemotherapy as first-line therapy in adult subjects with HER2 negative、advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two immunotherapy drugs (AK104 and AK112) together with chemotherapy for patients with advanced stomach or gastroesophageal junction cancer that cannot be surgically removed. The goal is to see if this combination is more effective than standard chemotherapy alone. **You may be eligible if...** - You are 18–75 years old - You have confirmed advanced or metastatic stomach cancer or gastroesophageal junction cancer (adenocarcinoma) - Your cancer cannot be removed by surgery and has measurable tumors on imaging - You have not received prior chemotherapy for advanced disease **You may NOT be eligible if...** - You have already received chemotherapy for advanced disease - You have had radiation to lesions being assessed, unless there is other measurable disease - You have severe heart, liver, or kidney conditions - You have active autoimmune disease that may interact with immunotherapy 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

BIOLOGICALCadonilimab

Subjects will receive AK104 by intravenous administration

BIOLOGICALIvonescimab

Subjects will receive AK112 by intravenous administration

DRUGXELOX

Subjects will receive AK104 and AK112 in combination with XELOX(oxaliplatin and capecitabine)

DRUGSOX

Subjects will receive AK104 and AK112 in combination withSOX(oxaliplatin and Tegafur)

Locations(1)

Harbin Medical University Hospital

Harbin, China

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NCT06196697

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