Trial Title:
A Study of JAB-21822 in Patients With KRAS p.G12C Mutated Pancreatic Cancer
NCT ID:
NCT06008288
Condition:
KRAS P.G12C
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JAB-21822
Description:
800mg, orally QD with 21 days each cycle, treatment till disease progression or
intolerable toxicity or withdraw for other reasons
Arm group label:
JAB-21822
Other name:
Glecirasib
Summary:
This study is to evaluate the efficacy and safety of JAB-21822 monotherapy in adult
participants with KRAS G12C mutated pancreatic cancer
Detailed description:
This is a single-arm, open-label, multicenter phase 2 study to evaluate the efficacy and
safety of JAB-21822 monotherapy in adult participants with advanced KRAS p.G12C mutated
pancreatic cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histopathologically or cytologically confirmed pancreatic cancer with KRAS p.G12C
mutation identified through molecular testing.
- Previously progressed on or after gemcitabine-based and/or
FOFIRINOX/mFOFIRINOX/NALIRIFOX chemotherapy, no more than 2 lines of prior systemic
therapies.
- Participants with MSI-H/dMMR must experience anti-PD-1 therapy.
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) ā„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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Cancer Hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Tsinghua Changgung Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Sun, Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Provincial People's Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangsu Cancer Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Huashan Hospital, Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai Changhai Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University Cancer Instituteļ¼Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Start date:
October 27, 2023
Completion date:
November 2025
Lead sponsor:
Agency:
Jacobio Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Jacobio Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06008288
