NCT06008288招募中2 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 31
- 主要终点
- Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
JAB-21822
Experimental
Monotherapy
干预措施: JAB-21822 (Drug)
结局指标
主要结局
Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
时间窗: 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.
次要结局
- Duration of response (DOR)(Approximately 1.5 years)
- Time to response (TTR) by IRC according to RECIST 1.1(Approximately 1.5 years)
- Progression-free survival (PFS) by IRC according to RECIST 1.1(Approximately 1.5 years)
- Disease control rate (DCR) by IRC according to RECIST 1.1(Approximately 1.5 years)
- CA19-9 response rate (Applicable only to pancreatic cancer)(Approximately 1.5 years)
- Overall survival (OS)(Approximately 2.0 years)
- Number of participants with adverse events(Approximately 1.5 years)
研究者
研究点 (31)
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相关资讯
Glecirasib Receives Orphan Drug Designation from EMA for Pancreatic Cancer- Jacobio Pharma's glecirasib, a KRAS G12C inhibitor, has been granted orphan drug designation by the European Medicines Agency (EMA) for pancreatic cancer.
- Glecirasib previously received orphan drug designation from the FDA in the United States and breakthrough therapy designation from the CDE in China for pancreatic cancer.
- Clinical trial data presented at ASCO GI 2024 showed a cORR of 41.9% and a DCR of 93.5% in second-line and above KRAS G12C mutated pancreatic cancer patients.
- Ongoing pivotal trial (NCT06008288) is evaluating glecirasib in advanced KRAS G12C mutated pancreatic ductal adenocarcinoma (PDAC) and other solid tumors across 30 sites in China.last yearGlecirasib Shows Promise as Novel KRAS G12C Inhibitor in Solid Tumors- Glecirasib, a selective KRAS G12C inhibitor by Jacobio Pharmaceuticals, demonstrates promising clinical activity in advanced solid tumors with KRAS G12C mutations.
- In NSCLC patients who progressed on prior therapies, glecirasib achieved an objective response rate of 47.9% and a median progression-free survival of 8.2 months.
- Glecirasib also showed encouraging results in pancreatic cancer, with a 41.9% objective response rate and a median overall survival of 10.7 months.
- The drug exhibits a favorable safety profile with low rates of gastrointestinal toxicities, potentially improving patient tolerability and treatment adherence.2 years ago