A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combination Therapy in Subjects With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Number of subjects participants with adverse events
研究概览
简要总结
This is a Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combination Therapy in Subjects with KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
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
- •Subject with histologically proven, locally advanced or metastatic NSCLC for which has no standard treatment or the subject has been previously treated with first- or second-line systemic therapy.
- •Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a local laboratory.
- •Subject has measurable disease according to RECIST v1.
- •For phase 1b subjects who have no measurable lesions but whose disease can be evaluated are also acceptable.
排除标准
- •Subject with unstable or progressive central nervous system (CNS) metastases.
- •Subjects with clinically significant cardiovascular disease.
- •Subject with interstitial lung disease (ILD) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- •Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
- •Subject is pregnant or lactating.
研究组 & 干预措施
Phase 1b Dose escalation of D-1553 combination therapies
Phase 1b will determine maximal tolerated dose and/or recommended phase 2 dose of D-1553 in combination with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
干预措施: Other (Drug)
Phase 1b Dose escalation of D-1553 combination therapies
Phase 1b will determine maximal tolerated dose and/or recommended phase 2 dose of D-1553 in combination with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
干预措施: D-1553 (Drug)
Phase 2 of D-1553 combination therapies
Phase 2 will evaluate the efficacy and safety of D-1553 combined with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
干预措施: D-1553 (Drug)
Phase 2 of D-1553 combination therapies
Phase 2 will evaluate the efficacy and safety of D-1553 combined with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
干预措施: Other (Drug)
结局指标
主要结局
Number of subjects participants with adverse events
时间窗: Till study completion, approximately 3 years
Number of subjects participants with adverse events
Subject incidence of Dose-limiting toxicities (DLT)
时间窗: Through out the DLT period, approximately 21 days
Subject incidence of Dose-limiting toxicities (DLT)
Antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation
时间窗: Till study completion, approximately 3 years
Overall Response Rate (ORR, Complete Response \[CR\] + Partial Response \[PR\])
次要结局
未报告次要终点