A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma

Last updated: August 19, 2025
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Esophageal Disorders

Adenocarcinoma

Treatment

Irinotecan OR Paclitaxel or Trifluridine/tipiracil( FTD/TPI)

paclitaxel

IBI343

Clinical Study ID

NCT06238843
CIBI343A301
  • Ages > 18
  • All Genders

Study Summary

This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma to compare the progression free survival (PFS) and overall survival (OS)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able and willing to sign a written Informed Consent Form(ICF) and to comply withprotocol-specified visits and related procedures.

  2. Has histopathologically confirmed unresectable locally advanced or metastaticadenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).

  3. Has received and progressed on at least 2 lines of systemic therapy (anti-PD-(L)1 incombination with platinum or fluoropyrimidines, paclitaxel/docetaxel, irinotecan). Aprior (neo)adjuvant systemic therapy that ended within 6 months prior to diseaserelapse is defined as the first line therapy. The subject has ≤ 4 prior lines ofsystemic therapy.

  4. Has histopathologically confirmed CLDN18.2-positive disease.

  5. Is a man or woman of 18 years of age or older at the time of signing the ICF.

  6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Exclusion

Exclusion Criteria:

  1. Has HER2-positive (defined as immunohistochemistry [IHC] 3+, or IHC 2+ and positiveby in situ hybridization) disease.

  2. Is currently participating in another interventional clinical study, except when thesubject is during survival follow-up of an interventional clinical study.

  3. Has a history of treatment with topoisomerase inhibitorbased antibody-drugconjugate(s).

  4. Has received the last dose of an anti-cancer therapy (including traditional Chinesemedicine indicated for gastric cancer in the package insert, but excluding herbalprescriptions) within 4 weeks or 5 half-lives (whichever is shorter) prior to thefirst dose of study treatment.

  5. Plans to receive other anti-cancer therapy during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affectresponse assessment is allowed).

Study Design

Total Participants: 450
Treatment Group(s): 4
Primary Treatment: Irinotecan OR Paclitaxel or Trifluridine/tipiracil( FTD/TPI)
Phase: 3
Study Start date:
June 30, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, Beijing Municipality 2038349 100142
    China

    Active - Recruiting

  • Shikoku Cancer Center

    Matsuyama-Shi, Ehime 791-0280
    Japan

    Site Not Available

  • Shikoku Cancer Center

    Matsuyama 1926099, Ehime 1864226 791-0280
    Japan

    Active - Recruiting

  • Gunma Prefectural Cancer Center

    Ota-Shi, Gunma 1863501 373-8550
    Japan

    Active - Recruiting

  • Kure Medical Center And Chugoku Cancer Center

    Kure, Hirosima [Hiroshima] 737-0023
    Japan

    Site Not Available

  • Kure Medical Center And Chugoku Cancer Center

    Kure 1858296, Hirosima [Hiroshima] 737-0023
    Japan

    Active - Recruiting

  • Teine Keijinkai Hospital

    Sapporo-shi, Hokkaido 006-8555
    Japan

    Site Not Available

  • Teine Keijinkai Hospital

    Sapporo 2128295, Hokkaido 2130037 006-8555
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka 1863967, Hukuoka [Fukuoka] 811-1395
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka-shi, Hukuoka [Fukuoka] 811-1395
    Japan

    Site Not Available

  • Hyogo Cancer Center

    Akashi City, Hyogo 673-8558
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe-city, Hyogo 650-0047
    Japan

    Site Not Available

  • Hyogo Cancer Center

    Akashi 1847966, Hyōgo 1862047 673-8558
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital

    Kobe 1859171, Hyōgo 1862047 650-0047
    Japan

    Active - Recruiting

  • St. Marianna University Hospital

    Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • Yokohama City University Medical Center

    Yokohama-Shi, Kanagawa 232-0024
    Japan

    Site Not Available

  • St. Marianna University Hospital

    Kawasaki 1859642, Kanagawa 1860291 216-8511
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama 1848354, Kanagawa 1860291
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center

    Yokohama 1848354, Kanagawa 1860291 232-0024
    Japan

    Active - Recruiting

  • Kochi Health Sciences Center

    Kochi 1859146, Koti [Kochi] 781-8555
    Japan

    Active - Recruiting

  • Kochi Health Sciences Center

    Kochi-Shi, Koti [Kochi] 781-8555
    Japan

    Site Not Available

  • Kindai University Hospital

    Osakasayama-Shi, Osaka 1853904 589-8511
    Japan

    Active - Recruiting

  • The University of Osaka Hospital

    Suita-shi, Osaka 1853904 565-0871
    Japan

    Active - Recruiting

  • Saitama Medical University - International Medical Center

    Hidaka-Shi, Saitama 1853226 350-1298
    Japan

    Active - Recruiting

  • Saitama Prefectural Cancer Center

    Kitaadachi-Gun, Saitama 1853226 362-0806
    Japan

    Active - Recruiting

  • Chiba Cancer Center

    Chiba, Tiba [Chiba] 260-8717
    Japan

    Site Not Available

  • Chiba Cancer Center

    Chiba 2113015, Tiba [Chiba] 260-8717
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Komagome Hospital

    Bunkyō-Ku, Tokyo 1850144 113-8677
    Japan

    Active - Recruiting

  • University of Tokyo Hospital

    Bunkyō-Ku, Tokyo 1850144 113-8655
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR

    Koto, Tokyo 1850144 135-8550
    Japan

    Active - Recruiting

  • Gifu University Hospital

    Gifu, 501-1194
    Japan

    Site Not Available

  • Gifu University Hospital

    Gifu 1863641, 501-1194
    Japan

    Active - Recruiting

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    Osaka, 541-8567
    Japan

    Site Not Available

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    Osaka 1853909, 541-8567
    Japan

    Active - Recruiting

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