Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12C Mutation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Written informed consent
- •Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment
- •Subject must be ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Subjects with life expectancy ≥3 months.
- •Subjects must have at least one measurable lesion as defined by RECIST v1.
- •There was no serious organ dysfunction in the screening stage
- •Male or female subjects of reproductive age agree to use adequate contraception
排除标准
- •History of intestinal disease or major gastric surgery or inability to swallow oral medications
- •Other active cancer
- •Previously treated with KRAS G12C inhibitor
- •Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
- •Impaired heart function or clinically significant heart disease
- •Pregnant or breast-feeding
- •Previous allogeneic bone marrow transplant or organ transplant
- •Intended study subjects who were unable to abstain from alcohol during medication
- •Other unqualified conditions judged by the investigators
研究组 & 干预措施
Phase 1 Dose Exploration
Dose escalation of JAB-21822 to determine maximum tolerated dose.
干预措施: JAB-21822 (Drug)
Phase IIb
Patients with KRAS p.G12C mutant advanced non small cell lung cancer will be enrolled and treated at the monotherapy RP2D to evaluate the safety and efficacy.
干预措施: JAB-21822 (Drug)
Phase IIa Dose Expansion
Patients with KRAS p.G12C mutant advanced non small cell lung cancer or other solid tumors will be enrolled and treated at the monotherapy RP2D to evaluate the safety and preliminary efficacy.
干预措施: JAB-21822 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: up to 3 years
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase
时间窗: first 21 days
Number of participants with dose limiting toxicities
Overall response rate (ORR) by IRC (independent review committee)
时间窗: up to 3 years
ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1
次要结局
- Overall response rate (ORR) by investigator(up to 3 years)
- Disease Control Rate ( DCR )(up to 3 years)
- Peak Plasma Concentration (Cmax)(up to 3 years)
- Duration of response ( DOR )(up to 3 years)
- Progression-free survival (PFS)(up to 3 years)
- Time to response (TTR)(up to 3 years)