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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: control arm | Active Comparator | 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 |
|
| IBI343 monotherapy | Experimental | IBI343: Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | 233004 | China | ||
| Anhui Provincial Hospital |
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|
| IBI343 | Drug | Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles . |
|
|
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 |
| 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 |
| 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 |
| Hefei |
| Anhui |
| 230001 |
| China |
| The First Affiliated Hospital of USTC /Anhui Provincial Hospital | Hefei | Anhui | 230001 | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China |
| Lu'an People's Hospital of Anhui Province | Lu'an | Anhui | 237000 | China |
| The First Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | 241001 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350000 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350000 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| The second hospital of Lanzhou university | Lanzhou | Gansu | 730030 | China |
| Gansu Provincial Cancer Hospital | Lanzhou | Gansu | 730050 | China |
| Dongguan People's Hospital | Dongguan | Guangdong | 523018 | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 519041 | China |
| Guanxi Medical University Cancer Hospital | Nanning | Guangxi | 530000 | China |
| The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530000 | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050035 | China |
| The 2nd Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| Nanyang Central Hospital | Nanyang | Henan | 473005 | China |
| Puyang People's Hospital | Puyang | Henan | 457005 | China |
| The First Affiliated Hospital of Xinxiang Medical University | Weihui | Henan | 453100 | China |
| Xinyang Central Hospital | Xiangyang | Henan | 464300 | China |
| Henan Cancer hospital | Zhengzhou | Henan | 450008 | China |
| The First Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 463599 | China |
| Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Xiangyang Central Hospital | Xiangyang | Hubei | 441021 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410000 | China |
| Hunan Provincial Cancer Hospital | Changsha | Hunan | 410031 | China |
| Chenzhou No.1 People's Hospital | Chenzhou | Hunan | 423000 | China |
| Yueyang Central Hospital | Yueyang | Hunan | 414000 | China |
| Zhuzhou Central Hospital | Zhuzhou | Hunan | 412007 | China |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | 750306 | China |
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | 213000 | China |
| The First People's Hospital of Lianyunguang | Lianyungang | Jiangsu | 222061 | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
| The first affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221111 | China |
| Northern Jiangsu People's Hosipital | Yangzhou | Jiangsu | 225001 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| The Third Bethune hospital of Jilin University | Changchun | Jilin | China |
| Affiliated Zhongshan hospital of Dalian university | Dalian | Liaoning | 116001 | China |
| The second hospital of Dalin medical university | Dalian | Liaoning | 116027 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110000 | China |
| Nanjing Drum Tower Hospital | Nanjing | Nanjing | 210008 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750003 | China |
| Qinghai University Affiliated Hospital | Xining | Qinghai | 810012 | China |
| The First Affiliated Hospital Of XI'AN Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Linyi People's Hospital | Linyi | Shandong | 276002 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266003 | China |
| Renji Hospital, Medical College, Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200001 | China |
| Shanxi Cancer hospital | Taiyuan | Shanxi | 030013 | China |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | 030032 | China |
| The Seventh Affiliated Hospital,Sun Yat-sen University | Guangdong | Shenzhen | 518107 | China |
| Sichuan Cancer Hospital | Chengdu | Sichuan | 610041 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650100 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310005 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 314408 | China |
| The First Hospital of Jiaxing | Jiaxing | Zhejiang | 314001 | China |
| Jinhua Municipal Central Hospital | Jinhua | Zhejiang | 321000 | China |
| Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | 317099 | China |
| Taizhou Central Hospital | Taizhou | Zhejiang | 318001 | China |
| The firsr Affiliated hospital of Wenzhou medical university | Wenzhou | Zhejiang | 325000 | China |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Gifu University Hospital | Gifu | Gifu | 501-1194 | Japan |
| Gunma Prefectural Cancer Center | Ota-Shi | Gunma | 373-8550 | Japan |
| National Hospital Organization Kure Medical Center and Chugoku Cancer Center | Kure | Hirosima [Hiroshima] | 737-0023 | Japan |
| Teine Keijinkai Hospital | Sapporo | Hokkaido | 006-8555 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | Hukuoka [Fukuoka] | 811-1395 | Japan |
| Hyogo Cancer Center | Akashi | Hyōgo | 673-8558 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| St. Marianna University Hospital | Kawasaki | Kanagawa | 216-8511 | Japan |
| Yokohama City University Medical Center | Yokohama | Kanagawa | 232-0024 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| Kochi Health Sciences Center | Kochi | Koti [Kochi] | 781-8555 | Japan |
| Osaka Prefectural Hospital Organization - Osaka International Cancer Institute | Osaka | Osaka | 541-8567 | Japan |
| Kindai University Hospital | Osakasayama-Shi | Osaka | 589-8511 | Japan |
| The University of Osaka Hospital | Suita-shi | Osaka | 565-0871 | Japan |
| Saitama Medical University - International Medical Center | Hidaka-Shi | Saitama | 350-1298 | Japan |
| Saitama Prefectural Cancer Center | Kitaadachi-Gun | Saitama | 362-0806 | Japan |
| Chiba Cancer Center | Chiba | Tiba [Chiba] | 260-8717 | Japan |
| University of Tokyo Hospital | Bunkyō-Ku | Tokyo | 113-8655 | Japan |
| Tokyo Metropolitan Komagome Hospital | Bunkyō-Ku | Tokyo | 113-8677 | Japan |
| Cancer Institute Hospital of JFCR | Koto | Tokyo | 135-8550 | Japan |
| National Cancer Center Hospital | Tokyo | Tsukiji, Chuo-ku | 104-0045 | Japan |
| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D017239 | Paclitaxel |
| D014271 | Trifluridine |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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