Evaluating JAB-21822 for pancreatic cancer and other solid tumors with a specific mutation
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.
PHASE2 · Allist Pharmaceuticals, Inc. · NCT06008288
This study is testing a new drug called Glecirasib to see if it can help adults with advanced pancreatic cancer or other solid tumors that have a specific mutation and who haven't had success with other treatments.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Allist Pharmaceuticals, Inc. (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 31 sites (Hefei, Anhui and 30 other locations) |
| Trial ID | NCT06008288 on ClinicalTrials.gov |
What this trial studies
This phase II trial is a single-arm, multicenter, open-label study that focuses on adult patients with locally advanced or metastatic solid tumors harboring the KRAS p.G12C mutation. It includes patients with advanced pancreatic cancer who have progressed after or are intolerant to prior gemcitabine-based chemotherapy or FOLFIRINOX treatments, as well as those with other solid tumors who lack satisfactory alternative therapies. The primary aim is to assess the efficacy and safety of the drug Glecirasib in these populations.
Who should consider this trial
Good fit: Ideal candidates are adults with locally advanced or metastatic solid tumors, specifically those with the KRAS p.G12C mutation who have progressed after prior therapies.
Not a fit: Patients who have previously received a KRAS G12C inhibitor or have uncontrolled lung disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited treatment alternatives for advanced solid tumors.
How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hefei, Anhui and 30 other locations
- Anhui Provincial Cancer Hospital — Hefei, Anhui, China (RECRUITING)
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (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 — Beijing, Beijing Municipality, China (RECRUITING)
- Fujian Cancer Hospital — Fuzhou, Fujian, China (RECRUITING)
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
- Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
- The First Affiliated Hospital of Sun, Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
- Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (RECRUITING)
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (RECRUITING)
- Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
- Hubei Cancer Hospital — Wuhan, Hubei, China (RECRUITING)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
- Hunan Cancer Hospital — Changsha, Hunan, China (RECRUITING)
- Hunan Provincial People's Hospital — Changsha, Hunan, China (RECRUITING)
- Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (RECRUITING)
- Jiangsu Province Hospital — Nanjing, Jiangsu, China (RECRUITING)
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
- The First Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
- Shandong Cancer Hospital — Jinan, Shandong, China (RECRUITING)
- The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (NOT_YET_RECRUITING)
- Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
- Shanghai Changhai Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
- The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (RECRUITING)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)
- Tianjin Medical University Cancer Institute&Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (RECRUITING)
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Shanghai Allist Pharmaceuticals Co., Ltd
- Email: zhenhua.gong@allist.com.cn
- Phone: 86-21-80423288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: KRAS P.G12C, Pancreatic Cancer, Solid Tumor