Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
NCT ID: NCT05288205
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
240 participants
INTERVENTIONAL
2022-04-14
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose escalation
JAB-21822
KRAS G12C inhibitor
JAB-3312
SHP2 inhibitor
Dose expansion
JAB-21822
KRAS G12C inhibitor
JAB-3312
SHP2 inhibitor
Interventions
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JAB-21822
KRAS G12C inhibitor
JAB-3312
SHP2 inhibitor
Eligibility Criteria
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Inclusion Criteria
* Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors harboring KRAS p.G12C mutation who have failed or lack standard-of-care (SOC) or are unwilling to undergo or intolerant to SOC;
* Expected survival ≥ 3 months;
* Subjects must have at least one measurable lesion as defined by RECIST v1.1. If no measurable lesion untreated with radiation is selected as the target lesion, a lesion treated with radiation ≥ 4 weeks before the first dose and with progression confirmed by radiography may be selected as the target lesion;
* Eastern Cooperative Oncology Group(ECOG) performance status 0-1;
* The organ functions of subjects meet the criteria for the following laboratory parameters at screening;
* Subjects must be able to swallow oral medications without gastrointestinal abnormalities that significantly affect drug absorption
Exclusion Criteria
* Serious allergy to the investigational drug or excipients (such as microcrystalline cellulose, etc.);
* Patients with previous (≤ 6 months before the initiation of treatment) or current severe autoimmune diseases (including adverse reactions caused by previous anti- tumor immunotherapies), or autoimmune diseases requiring long-term systemic hormone therapy at immunosuppressive dose levels (prednisone \> 10 mg/day or equivalent drugs);
* HIV, hepatitis B virus(HBV), or hepatitis C virus(HCV) positive;
* Previous (≤ 6 months prior to the first dose) or current evidence of the following diseases: acute myocardial infarction, unstable angina and cerebrovascular accident;
* Subjects who have impaired cardiac functions or clinically significant cardiac diseases;
* Pregnant or lactating women
18 Years
ALL
No
Sponsors
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Allist Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Wang Wang Jie M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China
Pecking Union Medical College Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy Of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Captal Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fujian cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital Xiamen University
Xiamen, Fujian, China
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southem Medical University
Guangzhou, Guangdong, China
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
Shenzhen, Guangdong, China
Harbin Medical University Cancer Hospital-Mammary gland of internal
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hosipital Of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of Hust
Wuhan, Hubei, China
Renmin Hospital Of Wuhan University
Wuhan, Hubei, China
Xiangya Hospital Central South Univesity
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Hospital Of China Medical University
Shenyang, Liaoning, China
The Affilated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
LinYi Cancer Hospital
Linyi, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital Zhejiang School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
Role: CONTACT
References
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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.
Other Identifiers
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JAB-21822-1006
Identifier Type: -
Identifier Source: org_study_id
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