A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.
- Registration Number
- NCT06008288
- Lead Sponsor
- Allist Pharmaceuticals, Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 88
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JAB-21822 JAB-21822 Monotherapy
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) Approximately 1.5 years DOR is defined as the time from date of the first objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Time to response (TTR) by IRC according to RECIST 1.1 Approximately 1.5 years TTR is defined as the duration of time between the date of the first dose and the date of first documented response of either CR or PR.
Progression-free survival (PFS) by IRC according to RECIST 1.1 Approximately 1.5 years PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first.
Disease control rate (DCR) by IRC according to RECIST 1.1 Approximately 1.5 years DCR is defined as the proportion of participants with BOR of CR or PR or stable disease (SD)
CA19-9 response rate (Applicable only to pancreatic cancer) Approximately 1.5 years CA19-9 response rate is defined as the proportion of participants with CA19-9 response (achieving ≥50% decrease in CA19-9 serum levels).
Overall survival (OS) Approximately 2.0 years OS is defined as time from date of the first dose to date of death due to any cause.
Number of participants with adverse events Approximately 1.5 years Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
Trial Locations
- Locations (31)
Anhui Provincial Cancer Hospital
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, 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, China
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, 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, 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