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RecruitingNCT05288205Updated Aug 13, 2026

Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

A Phase 1/2 interventional study of JAB-21822 and JAB-3312 in KRAS P.G12C, Non-small Cell Lung Cancer and Colorectal Cancer, sponsored by Allist Pharmaceuticals, Inc.. Recruiting at 27 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Allist Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
240
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • KRAS P.G12C
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Pancreatic Ductal Carcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;
  • 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

Exclusion Criteria:

  • Patients with previous (≤ 3 years) or current tumors of other pathological types, except for cured cervical carcinoma in situ, ductal carcinoma in situ of the breast, prostatic intraepithelial neoplasia, superficial non-invasive bladder cancer, stage I skin cancer (except melanoma); subjects without recurrence or metastasis for > 3 years after treatment, without current evidence of tumor, and without significant risk of recurrence of previous malignant diseases in the opinion of the study doctor may also be enrolled;
  • 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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Dose escalation

    Drug: JAB-21822 · Drug: JAB-3312

  • Experimental
    Dose expansion

    Drug: JAB-21822 · Drug: JAB-3312

Interventions

  • DrugJAB-21822

    KRAS G12C inhibitor

  • DrugJAB-3312

    SHP2 inhibitor

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Approximately 2 years

  2. 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.

    Time frame: Approximately 2 years

Secondary outcomes

  1. 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

    Time frame: Approximately 2 years

  2. Objective response rate (ORR)

    ORR is defined as the proportion of participants with confirmed complete response or partial response

    Time frame: Approximately 2 years

  3. 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

    Time frame: Approximately 2 years

06

Study locations

3 of 27 sites recruiting
  • The First Affiliated Hospital of USTC Anhui Provincial Hospital
    Hefei, Anhui 230001, China
    Not yet recruiting
  • Pecking Union Medical College Hospital
    Beijing, Beijing Municipality 100005, China
    Not yet recruiting
  • Cancer Hospital Chinese Academy Of Medical Sciences
    Beijing, Beijing Municipality 100021, China
    Recruiting
  • Beijing Tiantan Hospital, Captal Medical University
    Beijing, Beijing Municipality 100070, China
    Not yet recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing Municipality 100142, China
    Recruiting
  • Peking University Third Hospital
    Beijing, Beijing Municipality 100191, China
    Recruiting
  • Beijing Chest Hospital, Capital Medical University
    Beijing, Beijing Municipality 101125, China
    Not yet recruiting
  • Fujian cancer Hospital
    Fuzhou, Fujian 350014, China
    Not yet recruiting
  • The First Affiliated Hospital Xiamen University
    Xiamen, Fujian 361003, China
    Not yet recruiting
  • The first Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
    Not yet recruiting
  • Zhujiang Hospital of Southem Medical University
    Guangzhou, Guangdong 510280, China
    Not yet recruiting
  • Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
    Shenzhen, Guangdong 518116, China
    Not yet recruiting
  • Harbin Medical University Cancer Hospital-Mammary gland of internal
    Harbin, Heilongjiang 150081, China
    Not yet recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan 450003, China
    Not yet recruiting
  • The First Affiliated Hosipital Of Zhengzhou University
    Zhengzhou, Henan 450052, China
    Not yet recruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
    Not yet recruiting
  • Tongji Hospital Tongji Medical College of Hust
    Wuhan, Hubei 430030, China
    Not yet recruiting
  • Renmin Hospital Of Wuhan University
    Wuhan, Hubei 430060, China
    Not yet recruiting
  • Xiangya Hospital Central South Univesity
    Changsha, Hunan 410008, China
    Not yet recruiting
  • Hunan Cancer Hospital
    Changsha, Hunan 410031, China
    Not yet recruiting
  • The First Hospital Of China Medical University
    Shenyang, Liaoning 110001, China
    Not yet recruiting
  • The Affilated Hospital of Inner Mongolia Medical University
    Hohhot, Neimenggu 750306, China
    Not yet recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
    Not yet recruiting
  • Shandong Cancer Hospital
    Jinan, Shandong 250117, China
    Not yet recruiting
  • LinYi Cancer Hospital
    Linyi, Shandong 276002, China
    Not yet recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    Not yet recruiting
  • The Second Affiliated Hospital Zhejiang School of Medicine
    Hangzhou, Zhejiang 310009, China
    Not yet recruiting
07

References and documents

Publications

  • 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. PubMed 41325755 ↗
  • 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. PubMed 40333694 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05288205
Lead sponsor
Allist Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Mar 21, 2022
Start date
Apr 14, 2022
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
Contact
zhenhua.gong@allist.com.cn
021-80423288
Wang Wang Jie M.D.
principal investigator · Peking University Cancer Hospital & Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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