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New drug IBI343 shows promise in advanced stomach cancer trial

NCT ID NCT06238843

Disease control Sponsor: Innovent Biologics (Suzhou) Co. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tests a new drug called IBI343 against standard treatments for people with advanced stomach or gastroesophageal junction cancer that has not responded to prior therapies. The trial includes 464 participants whose tumors have a specific marker (CLDN18.2) and lack another (HER2). The goal is to see if IBI343 can slow cancer growth and help people live longer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

464 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able and willing to sign a written Informed Consent Form(ICF) and to comply with protocol-specified visits and related procedures. 2. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma 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 in combination with platinum or fluoropyrimidines, paclitaxel/docetaxel, irinotecan). A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy. The subject has ≤ 4 prior lines of systemic 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 Criteria: 1. Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease. 2. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study. 3. Has a history of treatment with topoisomerase inhibitorbased antibody-drug conjugate(s). 4. Has received the last dose of an anti-cancer therapy (including traditional Chinese medicine indicated for gastric cancer in the package insert, but excluding herbal prescriptions) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first 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 affect response assessment is allowed).

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Contacts and locations

Locations

  • Affiliated Zhongshan hospital of Dalian university

    Dalian, Liaoning, 116001, China

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Cancer Institute Hospital of JFCR

    Koto, Tokyo, 135-8550, Japan

  • Chenzhou No.1 People's Hospital

    Chenzhou, Hunan, 423000, China

  • Chiba Cancer Center

    Chiba, Tiba [Chiba], 260-8717, Japan

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523018, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000, China

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003, China

  • Gifu University Hospital

    Gifu, Gifu, 501-1194, Japan

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 519041, China

  • Guanxi Medical University Cancer Hospital

    Nanning, Guangxi, 530000, China

  • Gunma Prefectural Cancer Center

    Ota-Shi, Gunma, 373-8550, Japan

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer hospital

    Zhengzhou, Henan, 450008, China

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 463599, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000, China

  • Hunan Provincial Cancer Hospital

    Changsha, Hunan, 410031, China

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558, Japan

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009, China

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000, China

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kindai University Hospital

    Osakasayama-Shi, Osaka, 589-8511, Japan

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Kochi Health Sciences Center

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

  • Linyi People's Hospital

    Linyi, Shandong, 276002, China

  • Lu'an People's Hospital of Anhui Province

    Lu'an, Anhui, 237000, China

  • Nanjing Drum Tower Hospital

    Nanjing, Nanjing, 210008, China

  • Nanyang Central Hospital

    Nanyang, Henan, 473005, China

  • National Cancer Center Hospital

    Tokyo, Tsukiji, Chuo-ku, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Hospital Organization Kure Medical Center and Chugoku Cancer Center

    Kure, Hirosima [Hiroshima], 737-0023, Japan

  • National Hospital Organization Kyushu Cancer Center

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

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • Northern Jiangsu People's Hosipital

    Yangzhou, Jiangsu, 225001, China

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032, China

  • Puyang People's Hospital

    Puyang, Henan, 457005, China

  • Qinghai University Affiliated Hospital

    Xining, Qinghai, 810012, China

  • Renji Hospital, Medical College, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200001, China

  • Saitama Medical University - International Medical Center

    Hidaka-Shi, Saitama, 350-1298, Japan

  • Saitama Prefectural Cancer Center

    Kitaadachi-Gun, Saitama, 362-0806, Japan

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032, China

  • Shanxi Cancer hospital

    Taiyuan, Shanxi, 030013, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110000, China

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041, China

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

  • St. Marianna University Hospital

    Kawasaki, Kanagawa, 216-8511, Japan

  • Taizhou Central Hospital

    Taizhou, Zhejiang, 318001, China

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317099, China

  • Teine Keijinkai Hospital

    Sapporo, Hokkaido, 006-8555, Japan

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 750306, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003, China

  • The First Affiliated Hospital Of XI'AN Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350000, China

  • The First Affiliated Hospital of USTC /Anhui Provincial Hospital

    Hefei, Anhui, 230001, China

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241001, China

  • The First Affiliated Hospital of Xinxiang Medical University

    Weihui, Henan, 453100, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314001, China

  • The First Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213000, China

  • The First People's Hospital of Lianyunguang

    Lianyungang, Jiangsu, 222061, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050035, China

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530000, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004, China

  • The Seventh Affiliated Hospital,Sun Yat-sen University

    Guangdong, Shenzhen, 518107, China

  • The Third Bethune hospital of Jilin University

    Changchun, Jilin, China

  • The University of Osaka Hospital

    Suita-shi, Osaka, 565-0871, Japan

  • The firsr Affiliated hospital of Wenzhou medical university

    Wenzhou, Zhejiang, 325000, China

  • The first affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The second hospital of Dalin medical university

    Dalian, Liaoning, 116027, China

  • The second hospital of Lanzhou university

    Lanzhou, Gansu, 730030, China

  • Tokyo Metropolitan Komagome Hospital

    Bunkyō-Ku, Tokyo, 113-8677, Japan

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000, China

  • University of Tokyo Hospital

    Bunkyō-Ku, Tokyo, 113-8655, Japan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021, China

  • Xinyang Central Hospital

    Xiangyang, Henan, 464300, China

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221111, China

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024, Japan

  • Yueyang Central Hospital

    Yueyang, Hunan, 414000, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 314408, China

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412007, China

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