A Phase Ib,Open Label,Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 试验地点
- 13
- 主要终点
- Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
研究概览
简要总结
This study is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
详细描述
The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or cytologically confirmed, locally advanced or metastatic NSCLC, harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable);
- •No previous treatment or first-line treatment failed NSCLC;
- •At least 1 measurable lesion according to RECIST 1.1;
- •ECOG score 0 or 1;
排除标准
- •Previously treated with EGFR antibody;
- •Symptomatic brain metastasis;
- •Interstitial pneumopathy;
- •Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or their excipients;
- •Receiving an investigational product in another clinical study within 4 weeks;
- •History of serious systemic diseases;
- •History of serious autoimmune diseases;
- •Pregnancy or lactating women.
研究组 & 干预措施
Dose Escalation Cohort
Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the "3 + 3" dose-escalation design.
The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).
干预措施: JMT101 (Drug)
Dose Expansion Cohort
Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
干预措施: JMT101 (Drug)
结局指标
主要结局
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
时间窗: From enrollment until 30 days after the last dose
次要结局
- Progression free survival (PFS).(From first dose to disease progression or end of study, an average of 1 year)
- Overall survival (OS).(From first dose to death or end of study, an average of 1 year)
- Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1(From first dose to disease progression or end of study, an average of 1 year)
- Disease control rate (DCR).(From first dose to disease progression or end of study, an average of 1 year)
- Half-life (T1/2) of JMT101.(From enrollment until 30 days after the last dose)
- Immunogenicity profile of JMT101.(From enrollment until 30 days after the last dose)
- Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.(From enrollment until 30 days after the last dose)
- Maximum measured plasma concentration (Cmax) of JMT101.(From enrollment until 30 days after the last dose)
- Time to maximum plasma concentration (Tmax) of JMT101.(From enrollment until 30 days after the last dose)
- Potential biomarkers detected in plasma circulating tumor DNA.(From enrollment up to disease progression, an average of 1 year)