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Recruiting Phase 2

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

NCT06008288 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2023-10-27
Last updated
2026-03-13

Condition(s) studied

KRAS P.G12CPancreatic CancerSolid Tumor

Investigational drug(s) / intervention(s)

JAB-21822 →

JAB-21822: 800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1. — 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.

Trial sites (31)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06008288 on ClinicalTrials.gov ↗ ← All trials in China