A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.
Recruiting · NCT06008288 · Interventional (participants receive a specific treatment) · Lead sponsor: Allist Pharmaceuticals, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
31 locations listed.
- Anhui Provincial Cancer Hospital - Hefei, Anhui, China
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China
- Peking Union Medical College Hospital - Beijing, Beijing Municipality, China
- Beijing Tsinghua Changgung Hospital - Beijing, Beijing Municipality, China
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing, Beijing Municipality, China
- Fujian Cancer Hospital - Fuzhou, Fujian, China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China
- Sun Yat-Sen University Cancer Center - Guangzhou, Guangdong, China
- The First Affiliated Hospital of Sun, Yat-sen University - Guangzhou, Guangdong, China
- Guangxi Medical University Cancer Hospital - Nanning, Guangxi, China
- Harbin Medical University Cancer Hospital - Harbin, Heilongjiang, China
- Henan Cancer Hospital - Zhengzhou, Henan, China
- The First Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China
- Hubei Cancer Hospital - Wuhan, Hubei, China
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China
- Hunan Cancer Hospital - Changsha, Hunan, China
- Hunan Provincial People's Hospital - Changsha, Hunan, China
- Jiangsu Cancer Hospital - Nanjing, Jiangsu, China
- Jiangsu Province Hospital - Nanjing, Jiangsu, China
- The First Affiliated Hospital of Nanchang University - Nanchang, Jiangxi, China
- The First Hospital of China Medical University - Shenyang, Liaoning, China
- Shandong Cancer Hospital - Jinan, Shandong, China
- The Affiliated Hospital of Qingdao University - Qingdao, Shandong, China
- Huashan Hospital, Fudan University - Shanghai, Shanghai Municipality, China
- Shanghai Changhai Hospital - Shanghai, Shanghai Municipality, China
- The First Affiliated Hospital of Xi'an Jiaotong University - Xi’an, Shanxi, China
- West China Hospital of Sichuan University - Chengdu, Sichuan, China
- Tianjin Medical University Cancer Institute＆Hospital - Tianjin, Tianjin Municipality, China
- The First Affiliated Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
- Zhejiang Cancer Hospital - Hangzhou, Zhejiang, China
- Zhejiang Provincial People's Hospital - Hangzhou, Zhejiang, China