A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.

March 11, 2026 updated by: Allist Pharmaceuticals, Inc.

A Single-arm, Multicenter, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JAB-21822 Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.

Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapy or are intolerant and lack satisfactory alternative treatment options, aiming to evaluate the efficacy and safety of Glecirasib in these patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a single-arm, multicenter, open-label, basket-design, pivotal phase II trial targeting adult patients with locally advanced or metastatic solid tumors harboring the KRAS p.G12C mutation. The included populations are:

  • Patients with advanced pancreatic cancer who have progressed or are intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatments.
  • Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapies or are intolerant and lack satisfactory alternative treatment options.

The study aims to evaluate the efficacy and safety of Glecirasib in these patient populations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer hospital
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Sun, Yat-sen University
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Provincial People's Hospital
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • The First Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
      • Qingdao, Shandong, China
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Huashan Hospital, Fudan University
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai Changhai Hospital
    • Shanxi
      • Xi’an, Shanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin Medical University Cancer Institute＆Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with the KRAS p.G12C mutation confirmed through testing using prospectively validated companion diagnostic reagents or clinical trial assay (CTA) methods.
  • Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors (excluding NSCLC and CRC).
  • Patients with pancreatic cancer must have progressed or been intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatment. Patients with other types of solid tumors must have progressed or been intolerant to prior systemic therapies and lack satisfactory alternative treatment options.

Exclusion Criteria:

  • Previously received a KRAS G12C inhibitor.
  • History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.) with clinical symptoms.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites.
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms.
  • Use of a drug with known risk of torsades de points (TdP) within 14 days prior to the first dose.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JAB-21822
Monotherapy
Drug: JAB-21822
800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
Other Names:
  • Glecirasib

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
Time Frame: Approximately 1.5 years
ORR is defined as the proportion of participants with confirmed complete response or partial response by IRC according to RECIST 1.1.
Approximately 1.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of response (DOR)
Time Frame: Approximately 1.5 years
DOR is defined as the time from date of the first objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Approximately 1.5 years
Time to response (TTR) by IRC according to RECIST 1.1
Time Frame: Approximately 1.5 years
TTR is defined as the duration of time between the date of the first dose and the date of first documented response of either CR or PR.
Approximately 1.5 years
Progression-free survival (PFS) by IRC according to RECIST 1.1
Time Frame: Approximately 1.5 years
PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first.
Approximately 1.5 years
Disease control rate (DCR) by IRC according to RECIST 1.1
Time Frame: Approximately 1.5 years
DCR is defined as the proportion of participants with BOR of CR or PR or stable disease (SD)
Approximately 1.5 years
Overall survival (OS)
Time Frame: Approximately 2.0 years
OS is defined as time from date of the first dose to date of death due to any cause.
Approximately 2.0 years
Number of participants with adverse events
Time Frame: Approximately 1.5 years
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
Approximately 1.5 years
CA19-9 response rate (Applicable only to pancreatic cancer)
Time Frame: Approximately 1.5 years
CA19-9 response rate is defined as the proportion of participants with CA19-9 response (achieving ≥50% decrease in CA19-9 serum levels).
Approximately 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allist Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shanghai Allist Pharmaceuticals, Shanghai Allist Pharmaceuticals Co.,Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JAB-21822-2001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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