RecruitingPhase 2NCT05702229

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma


Sponsor

AstraZeneca

Enrollment

163 participants

Start Date

Jan 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new drug combinations in people with advanced stomach or gastroesophageal junction cancer (the junction where the esophagus meets the stomach) who have not yet received treatment for their advanced disease. It focuses on tumors that express a protein called Claudin18.2. **You may be eligible if...** - You are 18 years or older and weigh more than 35 kg - You have been diagnosed with stomach or gastroesophageal junction cancer that cannot be removed with surgery or has spread - You have not received prior treatment for this advanced cancer - Your tumor tests positive for a protein called Claudin18.2 - You are in good enough health to tolerate treatment (ECOG score 0 or 1) - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your tumor is HER2-positive - You have untreated brain metastases or spinal cord compression - You have uncontrolled fluid buildup in the abdomen - You have active HIV, tuberculosis, hepatitis B or C - You have active autoimmune disease requiring systemic steroids - You have previously been treated with an immunotherapy drug 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

DRUGRilvegostomig

an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion

DRUGVolrustomig

an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion

DRUGFOLFOX

5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)

DRUGXELOX

capecitabine and oxaliplatin

DRUGAZD0901

an anti Claudin18.2 ADC; IV infusion

DRUG5-Fluorouracil

5-FU, IV infusion

DRUGCapecitabine

Oral take


Locations(44)

Research Site

Los Angeles, California, United States

Research Site

Los Angeles, California, United States

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Baton Rouge, Louisiana, United States

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Grand Rapids, Michigan, United States

Research Site

New Hyde Park, New York, United States

Research Site

New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Shirley, New York, United States

Research Site

The Bronx, New York, United States

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Pittsburgh, Pennsylvania, United States

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Beijing, China

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Hangzhou, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Kunming, China

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Wuhan, China

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Yinchuan, China

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Zhengzhou, China

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Chūōku, Japan

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Kashiwa, Japan

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Sunto-gun, Japan

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Elche(Alicante), Spain

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L'Hospitalet de Llobregat, Spain

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Madrid, Spain

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Madrid, Spain

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Santander, Spain

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Hsinchu, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Edinburgh, United Kingdom

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Leeds, United Kingdom

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London, United Kingdom

Research Site

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05702229


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