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This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental |
| |
| Dose expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-21822 | Drug | KRAS G12C inhibitor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| recommended phase-2 dose (RP2D). | RP2D should be selected based on a comprehensive assessment of maximum tolerated dose(MTD), toxicity, pharmacokinetic(PK) profile, and efficacy data. | Approximately 2 years |
| Number of participants with dose limiting toxicities | Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically significant abnormal laboratory value occurring in Cycle 1 (DLT assessment period), which is unrelated to progressive disease, concurrent disease, or concomitant medication but related to JAB-21822 and/or JAB-3312, and meets the criteria for DLT. | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with AEs | All patients participating in this study will be assessed for incidence and severity of AEs and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imagings and ophthalmological assessments | Approximately 2 years |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd | Contact | 021-80423288 | zhenhua.gong@allist.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wang Wang Jie M.D. | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC Anhui Provincial Hospital | Not yet recruiting | Hefei | Anhui | 230001 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41325755 | Derived | Zhong J, Zhao J, Duan J, Fang J, Fei K, Li X, Chen J, Wang Z, Chu Q, Yu Y, Liu Z, Zhang L, Zhao Y, Li X, Wu L, Xing L, Zhuang W, Fang X, Chang J, Pan Y, Dong X, Liu L, Bai C, Pan P, Song Q, Jin B, Cao B, Ye F, Shi J, Tang K, Wang-Gillam A, Ding Y, Bi C, Shao Y, Pang J, Wan R, Sun B, Xu J, Wang J; JAB-21822-1006 Study Group. Glecirasib plus sitneprotafib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 1/2a trial. Lancet Respir Med. 2026 Feb;14(2):163-173. doi: 10.1016/S2213-2600(25)00258-9. Epub 2025 Nov 29. | |
| 40333694 |
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| JAB-3312 |
| Drug |
SHP2 inhibitor |
|
ORR is defined as the proportion of participants with confirmed complete response or partial response |
| Approximately 2 years |
| Progression-free survival (PFS) | Period of time from the start of treatment to tumor progression or death from any cause (whichever occurs first) based on RECIST v1.1 | Approximately 2 years |
| Pecking Union Medical College Hospital |
| Not yet recruiting |
| Beijing |
| Beijing Municipality |
| 100005 |
| China |
| Cancer Hospital Chinese Academy Of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| Beijing Tiantan Hospital, Captal Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100070 | China |
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
| Beijing Chest Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 101125 | China |
| Fujian cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350014 | China |
| The First Affiliated Hospital Xiamen University | Not yet recruiting | Xiamen | Fujian | 361003 | China |
| The first Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
| Zhujiang Hospital of Southem Medical University | Not yet recruiting | Guangzhou | Guangdong | 510280 | China |
| Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center | Not yet recruiting | Shenzhen | Guangdong | 518116 | China |
| Harbin Medical University Cancer Hospital-Mammary gland of internal | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
| The First Affiliated Hosipital Of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
| Tongji Hospital Tongji Medical College of Hust | Not yet recruiting | Wuhan | Hubei | 430030 | China |
| Renmin Hospital Of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430060 | China |
| Xiangya Hospital Central South Univesity | Not yet recruiting | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410031 | China |
| The First Hospital Of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
| The Affilated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Neimenggu | 750306 | China |
| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250012 | China |
| Shandong Cancer Hospital | Not yet recruiting | Jinan | Shandong | 250117 | China |
| LinYi Cancer Hospital | Not yet recruiting | Linyi | Shandong | 276002 | China |
| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| The Second Affiliated Hospital Zhejiang School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
| Derived |
| Kang D, Wang Y, Lin Y, Ma WW, Morgensztern D, Leventakos K, Bi C, Ding Y, Xiong J, Yan M, Sun X, Wang P, Ma C, Wang Y. JAB-3312, a Potent Allosteric SHP2 Inhibitor That Enhances the Efficacy of RTK/RAS/MAPK and PD-1 Blockade Therapies. Clin Cancer Res. 2025 Jul 15;31(14):3019-3032. doi: 10.1158/1078-0432.CCR-24-3691. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D021441 | Carcinoma, Pancreatic Ductal |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D010190 | Pancreatic Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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