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 (G-HOPE-001) (G-HOPE-001)

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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）; Drug: IBI343

• Study Type: Interventional
• Enrollment (Actual): 464
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • The First Affiliated Hospital of Bengbu Medical University
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China, 230001
      • The First Affiliated Hospital of USTC /Anhui Provincial Hospital
    • Lu'an, Anhui, China, 237000
      • Lu'an People's Hospital of Anhui Province
    • Wuhu, Anhui, China, 241001
      • The First Affiliated Hospital of Wannan Medical College
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100032
      • Peking Union Medical College Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
    • Fuzhou, Fujian, China, 350000
      • The First Affiliated Hospital of Fujian Medical University
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • The Second Hospital of Lanzhou University
    • Lanzhou, Gansu, China, 730050
      • Gansu Provincial Cancer Hospital
  • Guangdong
    • Dongguan, Guangdong, China, 523018
      • Dongguan People's Hospital
    • Guangzhou, Guangdong, China, 519041
      • Guangdong Provincial People's Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530000
      • The People's Hospital Of Guangxi Zhuang Autonomous Region
    • Nanning, Guangxi, China, 530000
      • Guanxi Medical University Cancer Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050035
      • The Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
    • Harbin, Heilongjiang, China, 150001
      • The 2nd Affiliated Hospital of Harbin Medical University
  • Henan
    • Nanyang, Henan, China, 473005
      • Nanyang Central Hospital
    • Puyang, Henan, China, 457005
      • Puyang People's Hospital
    • Weihui, Henan, China, 453100
      • The First Affiliated Hospital of Xinxiang Medical University
    • Xiangyang, Henan, China, 464300
      • Xinyang Central Hospital
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 463599
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China, 450052
      • The First Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430000
      • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
    • Xiangyang, Hubei, China, 441021
      • Xiangyang Central Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410031
      • Hunan Provincial Cancer Hospital
    • Chenzhou, Hunan, China, 423000
      • Chenzhou No.1 people's Hospital
    • Yueyang, Hunan, China, 414000
      • Yueyang Central Hospital
    • Zhuzhou, Hunan, China, 412007
      • ZhuZhou Central Hospital
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 750306
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • The First People's Hospital of Changzhou
    • Lianyungang, Jiangsu, China, 222061
      • The First People's Hospital of Lianyunguang
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
    • Suzhou, Jiangsu, China, 215004
      • The Second Affiliated Hospital of Soochow University
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
    • Xuzhou, Jiangsu, China, 221111
      • Xuzhou Central Hospital
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hosipital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The Second Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China
      • The Third Bethune hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116001
      • Affiliated Zhongshan Hospital of Dalian University
    • Dalian, Liaoning, China, 116027
      • The second hospital of Dalin medical university
    • Shenyang, Liaoning, China, 110000
      • Shengjing Hospital of China Medical University
  • Nanjing
    • Nanjing, Nanjing, China, 210008
      • Nanjing Drum Tower Hospital
  • Ningxia
    • Yinchuan, Ningxia, China, 750003
      • General hospital of ningxia medical university
  • Qinghai
    • Xining, Qinghai, China, 810012
      • Qinghai University Affiliated Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
    • Linyi, Shandong, China, 276002
      • Linyi People's Hospital
    • Qingdao, Shandong, China, 266003
      • The Affiliated Hospital of Qingdao University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200001
      • Renji Hospital, Medical College, Shanghai Jiaotong University
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Cancer Hospital
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Bethune Hospital
  • Shenzhen
    • Guangdong, Shenzhen, China, 518107
      • The Seventh Affiliated Hospital,Sun Yat-sen University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China, 610041
      • Sichuan Cancer Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650100
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 314408
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
    • Jiaxing, Zhejiang, China, 314001
      • The First Hospital of Jiaxing
    • Jinhua, Zhejiang, China, 321000
      • Jinhua municipal central hospital
    • Taizhou, Zhejiang, China, 317099
      • Taizhou Hospital of Zhejiang Province
    • Taizhou, Zhejiang, China, 318001
      • Taizhou Central Hospital
    • Wenzhou, Zhejiang, China, 325000
      • The firsr Affiliated hospital of Wenzhou medical university
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Gifu
    • Gifu, Gifu, Japan, 501-1194
      • Gifu University Hospital
  • Gunma
    • Ota-Shi, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center
  • Hirosima [Hiroshima]
    • Kure, Hirosima [Hiroshima], Japan, 737-0023
      • National Hospital Organization Kure Medical Center and Chugoku Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 006-8555
      • Teine Keijinkai Hospital
  • Hukuoka [Fukuoka]
    • Fukuoka, Hukuoka [Fukuoka], Japan, 811-1395
      • National Hospital Organization Kyushu Cancer Center
  • Hyōgo
    • Akashi, Hyōgo, Japan, 673-8558
      • Hyogo Cancer Center
    • Kobe, Hyōgo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 216-8511
      • St. Marianna University Hospital
    • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center
  • Koti [Kochi]
    • Kochi, Koti [Kochi], Japan, 781-8555
      • Kochi Health Sciences Center
  • Osaka
    • Osaka, Osaka, Japan, 541-8567
      • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
    • Osakasayama-Shi, Osaka, Japan, 589-8511
      • Kindai University Hospital
    • Suita-shi, Osaka, Japan, 565-0871
      • The University of Osaka Hospital
  • Saitama
    • Hidaka-Shi, Saitama, Japan, 350-1298
      • Saitama Medical University - International Medical Center
    • Kitaadachi-Gun, Saitama, Japan, 362-0806
      • Saitama Prefectural Cancer Center
  • Tiba [Chiba]
    • Chiba, Tiba [Chiba], Japan, 260-8717
      • Chiba cancer center
  • Tokyo
    • Bunkyō-Ku, Tokyo, Japan, 113-8677
      • Tokyo Metropolitan Komagome Hospital
    • Bunkyō-Ku, Tokyo, Japan, 113-8655
      • University of Tokyo Hospital
    • Koto, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital of JFCR
  • Tsukiji, Chuo-ku
    • Tokyo, Tsukiji, Chuo-ku, Japan, 104-0045
      • National Cancer Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: control arm; There are three drugs ( irinotecan, paclitaxel,or FTD/TPI (only are applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment)) in active contral arm, the subjects will receive the drug based on investigator's choice	Drug: Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）; Drugs: Irinotecan Subjects in the control arm will receive irnotecan 150mg/m2 IV D1, D15, Q4W in 4-weeks cycles. Drugs: Paclitaxel Subjects in the control arm will receive paclitaxel 80mg/m2 IV D1, D8, D15, Q4W in 4-week cycles, Drugs:FTD/TPI Subjects in the control arm will receive FTD/TPI 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment).
Experimental: IBI343 monotherapy; IBI343: Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .	Drug: IBI343; Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .; Other Names: Arcotatug Tavatecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival(PFS)	Progression-free survival (PFS) is defined as the time from random assignment in the trial to disease progression or death from any cause.	within approximately 20 months
overall survival(OS)	Overall survival (OS) is defined as the time from randomization to death from any cause.	within approximately 26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) as assessed by the IRRC per RECIST v1.1.	within approximately 20 months
disease control rate (DCR)	DCR is defined as the proportion of subjects in the analysis population who achieve disease control (CR, PR, or SD) as determined by the IRRC per RECIST v1.1 criteria.	within approximately 20 months
duration of response (DoR)	DoR is defined as the time from the first CR or PR to disease progression or death from any cause, whichever occurs first for subjects with ORR as assessed by IRRC per RECIST v1.1 criteria.	within approximately 20 months
time to response (TTR)	TTR is defined as the time from randomization to the first CR or PR for subjects with ORR as assessed by IRRC per RECIST v1.1 criteria.	within approximately 20 months
area under the curve (AUC)	Area under the curve (AUC) is defined as the area under the plasma concentration versus time curve.	within approximately 20 months
maximum concentration (Cmax)	Cmax is the highest concentration of a drug in the blood after the drug has been administered and before the administration of a second dose.	within approximately 20 months
time to maximum concentration(Tmax)	The time it takes for a drug to reach the maximum concentration (Cmax) after administration of the drug	within approximately 20 months
trough concentration (Ctrough)	Ctrough is the lowest concentration of a drug in the blood after the drug has been administered and before the administration of a second dose.	within approximately 20 months
clearance (CL)	The clearance is defined as the plasma volume in the vascular compartment that is cleared of drug per unit of time.	within approximately 20 months
volume of distribution (V)	Volume of distribution (Vd) is defined as the arrangement or rate of incidence of a drug in the body in relation to the measured plasma concentration.	within approximately 20 months
neutralizing antibody (NAb)	Neutralizing antibodies (NAb) are a subset of binding ADA that bind to the drug and inhibit its pharmacological function by preventing target binding.	within approximately 20 months
Incidence of anti-drug antibody (ADA)	Incidence of anti-drug antibody (ADA) is defined as the sum of both treatmentinduced (post-baseline ADA-positive only) and treatment-boosted ADA.	within approximately 20 months

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Esophageal Neoplasms; Adenocarcinoma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Taxoids; Cyclodecanes; Diterpenes; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Deoxyribonucleosides; Thymidine; Irinotecan; Paclitaxel; Trifluridine
• Other Study ID Numbers: CIBI343A301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes