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Clinical Trials in China / NCT06238843
Active, not recruiting Phase 3

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)

NCT06238843 · tracked via the Priya Life Science China tracker
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Phase
Phase 3
Started
2024-06-30
Last updated
2026-05-13

Condition(s) studied

Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

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

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).

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

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (95)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui
Anhui Provincial Hospital Hefei Anhui
The First Affiliated Hospital of USTC /Anhui Provincial Hospital Hefei Anhui
The First Affiliated Hospital of Anhui Medical University Hefei Anhui
Lu'an People's Hospital of Anhui Province Lu'an Anhui
The First Affiliated Hospital of Wannan Medical College Wuhu Anhui
Peking Union Medical College Hospital Beijing Beijing Municipality
Beijing Cancer Hospital Beijing Beijing Municipality
Fujian Medical University Union Hospital Fuzhou Fujian
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
Fujian Cancer Hospital Fuzhou Fujian
The second hospital of Lanzhou university Lanzhou Gansu
Gansu Provincial Cancer Hospital Lanzhou Gansu
Dongguan People's Hospital Dongguan Guangdong
Guangdong Provincial People's Hospital Guangzhou Guangdong
Guanxi Medical University Cancer Hospital Nanning Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
The 2nd Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
Harbin Medical University Cancer Hospital Harbin Heilongjiang
Nanyang Central Hospital Nanyang Henan
Puyang People's Hospital Puyang Henan
The First Affiliated Hospital of Xinxiang Medical University Weihui Henan
Xinyang Central Hospital Xiangyang Henan
Henan Cancer hospital Zhengzhou Henan
The First Hospital of Zhengzhou University Zhengzhou Henan
Henan Provincial People's Hospital Zhengzhou Henan
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Hubei Cancer Hospital Wuhan Hubei
Xiangyang Central Hospital Xiangyang Hubei
Hunan Cancer Hospital Changsha Hunan
Hunan Provincial Cancer Hospital Changsha Hunan
Chenzhou No.1 People's Hospital Chenzhou Hunan
Yueyang Central Hospital Yueyang Hunan
Zhuzhou Central Hospital Zhuzhou Hunan
The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia
The First People's Hospital of Changzhou Changzhou Jiangsu
The First People's Hospital of Lianyunguang Lianyungang Jiangsu
Jiangsu Cancer Hospital Nanjing Jiangsu
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu

+ 55 more sites — see the full list on the official registry below.

More Innovent Biologics (Suzhou) Co. Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06238843 on ClinicalTrials.gov ↗ ← All trials in China