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Double attack on mutant KRAS: can two targeted drugs outsmart resistant cancers?

NCT ID NCT05288205

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This early-phase trial is testing whether combining two experimental drugs, JAB-21822 and JAB-3312, can safely shrink or control advanced solid tumors that carry a specific KRAS G12C mutation. The study includes people with cancers like non-small cell lung, colorectal, or pancreatic cancer who have run out of standard options. The goal is to find the best dose and see how well the combination works against these hard-to-treat tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of two experimental targeted drugs: JAB-21822 (a KRAS G12C inhibitor) and JAB-3312 (an SHP2 inhibitor)
What this could lead to
If this combination works, it could offer a new treatment option for people with advanced cancers that carry a specific KRAS mutation, potentially shrinking tumors and slowing disease progression.
What could go wrong
This is an early-phase trial, so the safety and effectiveness are not yet proven. The combination may cause side effects or may not work for everyone. Success in this small study does not guarantee broader benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Beijing Chest Hospital, Capital Medical University

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 101125, China

  • Beijing Tiantan Hospital, Captal Medical University

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100070, China

  • Cancer Hospital Chinese Academy Of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center

    NOT_YET_RECRUITING

    Shenzhen, Guangdong, 518116, China

  • Fudan University Shanghai Cancer Center

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian cancer Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350014, 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

  • Hunan Cancer Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, 410031, China

  • LinYi Cancer Hospital

    NOT_YET_RECRUITING

    Linyi, Shandong, 276002, China

  • Pecking Union Medical College Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100005, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100191, China

  • Qilu Hospital of Shandong University

    NOT_YET_RECRUITING

    Jinan, Shandong, 250012, China

  • Renmin Hospital Of Wuhan University

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430060, China

  • Shandong Cancer Hospital

    NOT_YET_RECRUITING

    Jinan, Shandong, 250117, China

  • The Affilated Hospital of Inner Mongolia Medical University

    NOT_YET_RECRUITING

    Hohhot, Neimenggu, 750306, China

  • The First Affiliated Hosipital Of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital Xiamen University

    NOT_YET_RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of USTC Anhui Provincial Hospital

    NOT_YET_RECRUITING

    Hefei, Anhui, 230001, China

  • The First Hospital Of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110001, China

  • The Second Affiliated Hospital Zhejiang School of Medicine

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • The first Affiliated Hospital, Sun Yat-sen University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Tongji Hospital Tongji Medical College of Hust

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430030, China

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

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

  • Xiangya Hospital Central South Univesity

    NOT_YET_RECRUITING

    Changsha, Hunan, 410008, China

  • Zhujiang Hospital of Southem Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510280, China

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