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AzTrials

Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaPhase 3G-HOPE-001NCT06238843

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)

A Phase 3 study testing Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI） and IBI343 in people with Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 95 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI） and IBI343
Could I receive a placebo?
No, everyone receives an active treatment
How many people
464 participants
Where
95 sitesin 2 countries
Study dates
30 Jun 2024to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to sign a written Informed Consent Form(ICF) and to comply with protocol-specified visits and related procedures.
  • Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
  • 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.
  • 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.

Who cannot join

  • Has HER2-positive (defined as immunohistochemistry [IHC] 3+, or IHC 2+ and positive by in situ hybridization) disease.
  • Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
  • Has a history of treatment with topoisomerase inhibitorbased antibody-drug conjugate(s).
  • 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.
  • 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).

Trial locations and contacts

95 sites in 2 countries.

95 sites in 2 countries

China72 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233004

  • The Third Bethune hospital of Jilin University

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

  • Hunan Provincial Cancer Hospital

    Changsha, Hunan, 410031

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213000

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Chenzhou No.1 People's Hospital

    Chenzhou, Hunan, 423000

  • Affiliated Zhongshan hospital of Dalian university

    Dalian, Liaoning, 116001

  • The second hospital of Dalin medical university

    Dalian, Liaoning, 116027

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523018

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350000

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • The Seventh Affiliated Hospital,Sun Yat-sen University

    Guangdong, Shenzhen, 518107

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 519041

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 314408

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • The First Affiliated Hospital of USTC /Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 750306

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314001

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100

  • The second hospital of Lanzhou university

    Lanzhou, Gansu, 730030

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050

  • The First People's Hospital of Lianyunguang

    Lianyungang, Jiangsu, 222061

  • Linyi People's Hospital

    Linyi, Shandong, 276002

  • Lu'an People's Hospital of Anhui Province

    Lu'an, Anhui, 237000

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Nanjing Drum Tower Hospital

    Nanjing, Nanjing, 210008

  • Guanxi Medical University Cancer Hospital

    Nanning, Guangxi, 530000

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530000

  • Nanyang Central Hospital

    Nanyang, Henan, 473005

  • Puyang People's Hospital

    Puyang, Henan, 457005

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

  • Renji Hospital, Medical College, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200001

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050035

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • The first affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Shanxi Cancer hospital

    Taiyuan, Shanxi, 030013

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317099

  • Taizhou Central Hospital

    Taizhou, Zhejiang, 318001

  • The First Affiliated Hospital of Xinxiang Medical University

    Weihui, Henan, 453100

  • The firsr Affiliated hospital of Wenzhou medical university

    Wenzhou, Zhejiang, 325000

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

    Wuhan, Hubei, 430000

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

  • The First Affiliated Hospital Of XI'AN Jiaotong University

    Xi'an, Shaanxi, 710061

  • Xinyang Central Hospital

    Xiangyang, Henan, 464300

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

  • Qinghai University Affiliated Hospital

    Xining, Qinghai, 810012

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221111

  • Northern Jiangsu People's Hosipital

    Yangzhou, Jiangsu, 225001

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003

  • Yueyang Central Hospital

    Yueyang, Hunan, 414000

  • Henan Cancer hospital

    Zhengzhou, Henan, 450008

  • The First Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 463599

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412007

Other trials in China

Japan23 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • University of Tokyo Hospital

    Bunkyō-Ku, Tokyo, 113-8655

  • Tokyo Metropolitan Komagome Hospital

    Bunkyō-Ku, Tokyo, 113-8677

  • Chiba Cancer Center

    Chiba, Tiba [Chiba], 260-8717

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Hukuoka [Fukuoka], 811-1395

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • Saitama Medical University - International Medical Center

    Hidaka-Shi, Saitama, 350-1298

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • St. Marianna University Hospital

    Kawasaki, Kanagawa, 216-8511

  • Saitama Prefectural Cancer Center

    Kitaadachi-Gun, Saitama, 362-0806

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kochi Health Sciences Center

    Kochi, Koti [Kochi], 781-8555

  • Cancer Institute Hospital of JFCR

    Koto, Tokyo, 135-8550

  • National Hospital Organization Kure Medical Center and Chugoku Cancer Center

    Kure, Hirosima [Hiroshima], 737-0023

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Kindai University Hospital

    Osakasayama-Shi, Osaka, 589-8511

  • Gunma Prefectural Cancer Center

    Ota-Shi, Gunma, 373-8550

  • Teine Keijinkai Hospital

    Sapporo, Hokkaido, 006-8555

  • The University of Osaka Hospital

    Suita-shi, Osaka, 565-0871

  • National Cancer Center Hospital

    Tokyo, Tsukiji, Chuo-ku, 104-0045

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

About this study

Official title: 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)

Being tested
Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）, IBI343

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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).

  • IBI343Drug

    Also called Arcotatug Tavatecan

    Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .

Study groups in NCT06238843
Study groupRoleWhat they receive
Active Comparator: control armActive comparatorThere 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
Receives: Drug: Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）
IBI343 monotherapyExperimentalIBI343: Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .
Receives: Drug: IBI343

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within approximately 20 months

  2. overall survival(OS)

    Overall survival (OS) is defined as the time from randomization to death from any cause.

    Measured: within approximately 26 months

Secondary outcomes (12)

  1. 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.

    Measured: within approximately 20 months

  2. 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.

    Measured: within approximately 20 months

  3. 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.

    Measured: within approximately 20 months

  4. 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.

    Measured: within approximately 20 months

  5. area under the curve (AUC)

    Area under the curve (AUC) is defined as the area under the plasma concentration versus time curve.

    Measured: within approximately 20 months

  6. 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.

    Measured: within approximately 20 months

  7. time to maximum concentration(Tmax)

    The time it takes for a drug to reach the maximum concentration (Cmax) after administration of the drug

    Measured: within approximately 20 months

  8. 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.

    Measured: within approximately 20 months

  9. clearance (CL)

    The clearance is defined as the plasma volume in the vascular compartment that is cleared of drug per unit of time.

    Measured: within approximately 20 months

  10. 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.

    Measured: within approximately 20 months

  11. 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.

    Measured: within approximately 20 months

  12. 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.

    Measured: within approximately 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2024
  2. Study start30 Jun 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06238843
Sponsor's protocol ID
CIBI343A301
Acronym
G-HOPE-001
Status last verified
May 2026
First submitted
25 Jan 2024
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI） and IBI343 in people with Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 95 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival(PFS) (time frame: within approximately 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06238843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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