Phase
Condition
Digestive System Neoplasms
Esophageal Disorders
Adenocarcinoma
Treatment
Irinotecan OR Paclitaxel or Trifluridine/tipiracil( FTD/TPI)
paclitaxel
IBI343
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able and willing to sign a written Informed Consent Form(ICF) and to comply withprotocol-specified visits and related procedures.
Has histopathologically confirmed unresectable locally advanced or metastaticadenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
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.
Has histopathologically confirmed CLDN18.2-positive disease.
Is a man or woman of 18 years of age or older at the time of signing the ICF.
Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Exclusion
Exclusion Criteria:
Has HER2-positive (defined as immunohistochemistry [IHC] 3+, or IHC 2+ and positiveby in situ hybridization) disease.
Is currently participating in another interventional clinical study, except when thesubject is during survival follow-up of an interventional clinical study.
Has a history of treatment with topoisomerase inhibitorbased antibody-drugconjugate(s).
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.
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
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaSite Not Available
Beijing Cancer Hospital
Beijing 1816670, Beijing Municipality 2038349 100142
ChinaActive - Recruiting
Shikoku Cancer Center
Matsuyama-Shi, Ehime 791-0280
JapanSite Not Available
Shikoku Cancer Center
Matsuyama 1926099, Ehime 1864226 791-0280
JapanActive - Recruiting
Gunma Prefectural Cancer Center
Ota-Shi, Gunma 1863501 373-8550
JapanActive - Recruiting
Kure Medical Center And Chugoku Cancer Center
Kure, Hirosima [Hiroshima] 737-0023
JapanSite Not Available
Kure Medical Center And Chugoku Cancer Center
Kure 1858296, Hirosima [Hiroshima] 737-0023
JapanActive - Recruiting
Teine Keijinkai Hospital
Sapporo-shi, Hokkaido 006-8555
JapanSite Not Available
Teine Keijinkai Hospital
Sapporo 2128295, Hokkaido 2130037 006-8555
JapanActive - Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka 1863967, Hukuoka [Fukuoka] 811-1395
JapanActive - Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi, Hukuoka [Fukuoka] 811-1395
JapanSite Not Available
Hyogo Cancer Center
Akashi City, Hyogo 673-8558
JapanSite Not Available
Kobe City Medical Center General Hospital
Kobe-city, Hyogo 650-0047
JapanSite Not Available
Hyogo Cancer Center
Akashi 1847966, Hyōgo 1862047 673-8558
JapanActive - Recruiting
Kobe City Medical Center General Hospital
Kobe 1859171, Hyōgo 1862047 650-0047
JapanActive - Recruiting
St. Marianna University Hospital
Kawasaki, Kanagawa 216-8511
JapanSite Not Available
Yokohama City University Medical Center
Yokohama-Shi, Kanagawa 232-0024
JapanSite Not Available
St. Marianna University Hospital
Kawasaki 1859642, Kanagawa 1860291 216-8511
JapanActive - Recruiting
Kanagawa Cancer Center
Yokohama 1848354, Kanagawa 1860291
JapanActive - Recruiting
Yokohama City University Medical Center
Yokohama 1848354, Kanagawa 1860291 232-0024
JapanActive - Recruiting
Kochi Health Sciences Center
Kochi 1859146, Koti [Kochi] 781-8555
JapanActive - Recruiting
Kochi Health Sciences Center
Kochi-Shi, Koti [Kochi] 781-8555
JapanSite Not Available
Kindai University Hospital
Osakasayama-Shi, Osaka 1853904 589-8511
JapanActive - Recruiting
The University of Osaka Hospital
Suita-shi, Osaka 1853904 565-0871
JapanActive - Recruiting
Saitama Medical University - International Medical Center
Hidaka-Shi, Saitama 1853226 350-1298
JapanActive - Recruiting
Saitama Prefectural Cancer Center
Kitaadachi-Gun, Saitama 1853226 362-0806
JapanActive - Recruiting
Chiba Cancer Center
Chiba, Tiba [Chiba] 260-8717
JapanSite Not Available
Chiba Cancer Center
Chiba 2113015, Tiba [Chiba] 260-8717
JapanActive - Recruiting
Tokyo Metropolitan Komagome Hospital
Bunkyō-Ku, Tokyo 1850144 113-8677
JapanActive - Recruiting
University of Tokyo Hospital
Bunkyō-Ku, Tokyo 1850144 113-8655
JapanActive - Recruiting
Cancer Institute Hospital of JFCR
Koto, Tokyo 1850144 135-8550
JapanActive - Recruiting
Gifu University Hospital
Gifu, 501-1194
JapanSite Not Available
Gifu University Hospital
Gifu 1863641, 501-1194
JapanActive - Recruiting
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Osaka, 541-8567
JapanSite Not Available
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Osaka 1853909, 541-8567
JapanActive - Recruiting

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