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

Last updated: April 7, 2025
Sponsor: Allist Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatic Cancer

Neuroblastoma

Pancreatic Disorders

Treatment

JAB-21822

Clinical Study ID

NCT06008288
JAB-21822-2001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with the KRAS p.G12C mutation confirmed through testing using prospectivelyvalidated companion diagnostic reagents or clinical trial assay (CTA) methods.

  • Histologically or cytologically confirmed locally advanced unresectable ormetastatic solid tumors (excluding NSCLC and CRC).

  • Patients with pancreatic cancer must have progressed or been intolerant to priorgemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOXtreatment. Patients with other types of solid tumors must have progressed or beenintolerant to prior systemic therapies and lack satisfactory alternative treatmentoptions.

Exclusion

Exclusion Criteria:

  • Previously received a KRAS G12C inhibitor.

  • History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lungdisease (including pulmonary fibrosis, acute lung disease, etc.) with clinicalsymptoms.

  • Uncontrolled pleural effusion, pericardial effusion, or ascites.

  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 mscalculated from 3 electrocardiograms.

  • Use of a drug with known risk of torsades de points (TdP) within 14 days prior tothe first dose.

Study Design

Total Participants: 88
Treatment Group(s): 1
Primary Treatment: JAB-21822
Phase: 2
Study Start date:
October 27, 2023
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui
    China

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The First Affiliated Hospital of Sun, Yat-sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

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

    Wuhan, Hubei
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong
    China

    Site Not Available

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Shanghai Changhai Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute&Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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