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KRAS P.G12CPhase 1/2NCT05288205

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 study testing JAB-21822 and JAB-3312 in people with KRAS P.G12C and Non-small Cell Lung Cancer, run by Allist Pharmaceuticals, Inc. at 27 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JAB-21822 and JAB-3312
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
27 sitesChina
Study dates
14 Apr 2022to Mar 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd contact

021-80423288

zhenhua.gong@allist.com.cn

27 sites in 1 country

China27 sites, 27 recruiting

  • Pecking Union Medical College Hospital

    Beijing, Beijing Municipality, 100005

    Not yet recruiting

  • Cancer Hospital Chinese Academy Of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Recruiting

  • Beijing Tiantan Hospital, Captal Medical University

    Beijing, Beijing Municipality, 100070

    Not yet recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Recruiting

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101125

    Not yet recruiting

  • Xiangya Hospital Central South Univesity

    Changsha, Hunan, 410008

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Not yet recruiting

  • Fujian cancer Hospital

    Fuzhou, Fujian, 350014

    Not yet recruiting

  • The first Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Not yet recruiting

  • Zhujiang Hospital of Southem Medical University

    Guangzhou, Guangdong, 510280

    Not yet recruiting

  • The Second Affiliated Hospital Zhejiang School of Medicine

    Hangzhou, Zhejiang, 310009

    Not yet recruiting

  • Harbin Medical University Cancer Hospital-Mammary gland of internal

    Harbin, Heilongjiang, 150081

    Not yet recruiting

  • The First Affiliated Hospital of USTC Anhui Provincial Hospital

    Hefei, Anhui, 230001

    Not yet recruiting

  • The Affilated Hospital of Inner Mongolia Medical University

    Hohhot, Neimenggu, 750306

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Not yet recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Not yet recruiting

  • LinYi Cancer Hospital

    Linyi, Shandong, 276002

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Not yet recruiting

  • The First Hospital Of China Medical University

    Shenyang, Liaoning, 110001

    Not yet recruiting

  • Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center

    Shenzhen, Guangdong, 518116

    Not yet recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Not yet recruiting

  • Tongji Hospital Tongji Medical College of Hust

    Wuhan, Hubei, 430030

    Not yet recruiting

  • Renmin Hospital Of Wuhan University

    Wuhan, Hubei, 430060

    Not yet recruiting

  • The First Affiliated Hospital Xiamen University

    Xiamen, Fujian, 361003

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Not yet recruiting

  • The First Affiliated Hosipital Of Zhengzhou University

    Zhengzhou, Henan, 450052

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase 1/2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

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.

Being tested
JAB-21822, JAB-3312
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Carcinoma, Pancreatic Ductal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JAB-21822Drug

    KRAS G12C inhibitor

  • JAB-3312Drug

    SHP2 inhibitor

Study groups in NCT05288205
Study groupRoleWhat they receive
Dose escalationExperimentalNot described
Receives: Drug: JAB-21822; Drug: JAB-3312
Dose expansionExperimentalNot described
Receives: Drug: JAB-21822; Drug: JAB-3312

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Approximately 2 years

Secondary outcomes (3)

  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

    Measured: Approximately 2 years

  2. Objective response rate (ORR)

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

    Measured: 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

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2022
  2. Study start14 Apr 2022
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05288205
Sponsor's protocol ID
JAB-21822-1006
Status last verified
Aug 2026
First submitted
11 Mar 2022
Last updated
13 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JAB-21822 and JAB-3312 in people with KRAS P.G12C and Non-small Cell Lung Cancer, run by Allist Pharmaceuticals, Inc. at 27 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd (021-80423288, zhenhua.gong@allist.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recommended phase-2 dose (RP2D). (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05288205, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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