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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

88

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Allist Pharmaceuticals, Inc.

Investigators

  • 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)

October 27, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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