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

Last updated: May 13, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

AZD7789

XELOX

5-Fluorouracil

Clinical Study ID

NCT05702229
D7986C00001
2024-510977-27-00
2022-002840-29
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older at the time of signing the ICF.

  • Body weight > 35 kg.

  • Previously untreated for unresectable or metastatic gastric or gastroesophagealjunction adenocarcinoma.

  • Has measurable target disease assessed by the Investigator based on RECIST 1.1.

  • ECOG PS zero or one.

  • Life expectancy of at least 12 weeks.

  • Adequate organ and bone marrow function.

  • Has central lab confirmed Claudin18.2 status at screening from archival tumourcollected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 is open for recruitment.

Exclusion

Exclusion Criteria:

  • Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by insituhybridisation) or indeterminate gastric or GEJ carcinoma.

  • Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cordcompression.

  • Participants with ascites which cannot be controlled with appropriate interventions.

  • Active infectious diseases, including tuberculosis, HIV infection, or hepatitis B/C.

  • Uncontrolled intercurrent illness.

  • Active or prior documented autoimmune or inflammatory disorders requiring systemictreatment with steroids or other immunosuppressive treatment.

  • History of another primary malignancy.

  • Previous treatment with an immune-oncology agent.

  • Previous treatment with any modalities of Claudin18.2 target therapy or MMAEexposure (when Substudy 3, Substudy 4 is open for recruitment).

Study Design

Total Participants: 163
Treatment Group(s): 10
Primary Treatment: AZD7789
Phase: 2
Study Start date:
January 16, 2023
Estimated Completion Date:
May 31, 2029

Study Description

Approximately 360 participants will be assigned across 4 substudies, with approximately 60 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy/cohort.

Connect with a study center

  • Research Site

    Beijing, 100142
    China

    Active - Recruiting

  • Research Site

    Beijing 1816670, 100142
    China

    Site Not Available

  • Research Site

    Hangzhou, 310020
    China

    Active - Recruiting

  • Research Site

    Hangzhou 1808926, 310020
    China

    Site Not Available

  • Research Site

    Harbin, 150081
    China

    Active - Recruiting

  • Research Site

    Harbin 2037013, 150081
    China

    Site Not Available

  • Research Site

    Hefei, 230031
    China

    Active - Recruiting

  • Research Site

    Hefei 1808722, 230031
    China

    Site Not Available

  • Research Site

    Kunming, 650118
    China

    Completed

  • Research Site

    Kunming 1804651, 650118
    China

    Site Not Available

  • Research Site

    Wuhan, 430079
    China

    Active - Recruiting

  • Research Site

    Wuhan 1791247, 430079
    China

    Site Not Available

  • Research Site

    Yinchuan, 750004
    China

    Active - Recruiting

  • Research Site

    Yinchuan 1786657, 750004
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450052
    China

    Active - Recruiting

  • Research Site

    Zhengzhou 1784658, 450052
    China

    Site Not Available

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Site Not Available

  • Research Site

    Chūōku, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Chūōku 10262791, 104-0045
    Japan

    Site Not Available

  • Research Site

    Kashiwa, 227-8577
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa 1859924, 227-8577
    Japan

    Site Not Available

  • Research Site

    Sunto-gun, 411-8777
    Japan

    Active - Recruiting

  • Research Site

    Tokyo, 104-0045
    Japan

    Site Not Available

  • Research Site

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Research Site

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Research Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Research Site

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Research Site

    Elche(Alicante), 03202
    Spain

    Active - Recruiting

  • Research Site

    Elche(Alicante) 2518559, 03202
    Spain

    Site Not Available

  • Research Site

    L'Hospitalet de Llobregat, 08908
    Spain

    Active - Recruiting

  • Research Site

    L'Hospitalet de Llobregat 3120619, 08908
    Spain

    Site Not Available

  • Research Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • Research Site

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Research Site

    Santander, 39008
    Spain

    Active - Recruiting

  • Research Site

    Santander 3109718, 39008
    Spain

    Site Not Available

  • Research Site

    Hsinchu, 300
    Taiwan

    Active - Recruiting

  • Research Site

    Hsinchu 1675151, 300
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City, 80756
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung City 1673820, 80756
    Taiwan

    Site Not Available

  • Research Site

    Taichung, 404
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung 1668399, 404
    Taiwan

    Site Not Available

  • Research Site

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan 1668355, 70403
    Taiwan

    Site Not Available

  • Research Site

    Tainan City, 70403
    Taiwan

    Site Not Available

  • Research Site

    Tainan City 1668355, 70403
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 11259
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District, 333
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Research Site

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Research Site

    Edinburgh 2650225, EH4 2XU
    United Kingdom

    Site Not Available

  • Research Site

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • Research Site

    Leeds 2644688, LS9 7TF
    United Kingdom

    Site Not Available

  • Research Site

    London, EC1M 6BQ
    United Kingdom

    Active - Recruiting

  • Research Site

    London 2643743, EC1M 6BQ
    United Kingdom

    Site Not Available

  • Research Site

    Oxford, OX3 7LE
    United Kingdom

    Active - Recruiting

  • Research Site

    Oxford 2640729, OX3 7LE
    United Kingdom

    Site Not Available

  • Research Site

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Research Site

    Los Angeles 5368361, California 5332921 90017
    United States

    Site Not Available

  • Research Site

    Baton Rouge, Louisiana 70817
    United States

    Active - Recruiting

  • Research Site

    Baton Rouge 4315588, Louisiana 4331987 70817
    United States

    Site Not Available

  • Research Site

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Research Site

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Site Not Available

  • Research Site

    Bronx, New York 10469
    United States

    Site Not Available

  • Research Site

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Research Site

    New York, New York 10028
    United States

    Site Not Available

  • Research Site

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Research Site

    Shirley, New York 11967
    United States

    Site Not Available

  • Research Site

    The Bronx, New York 10469
    United States

    Site Not Available

  • Research Site

    New Hyde Park 5128514, New York 5128638 11042
    United States

    Site Not Available

  • Research Site

    New York 5128581, New York 5128638 11210
    United States

    Site Not Available

  • Research Site

    Shirley 5138022, New York 5128638 11967
    United States

    Site Not Available

  • Research Site

    The Bronx 5110266, New York 5128638 10469
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Research Site

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

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