A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Subject incidence of Dose-limiting toxicities (DLT)
研究概览
简要总结
This is a phase 1/2, open label study of D-1553 single agent treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic NSCLC with KRasG12C mutation
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, unresectable and/or metastatic NSCLC for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment.
- •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 central laboratory.
- •Subject has measurable disease according to RECIST, v1.1
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 1a Dose escalation of D-1553
Phase 1a will evaluate up to sequential cohorts with different doses of D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation
干预措施: D-1553 (Drug)
Phase 1b Dose expansion of D-1553
Phase 1b will evaluate more subjects with up to 2 different doses of D-1553 to confirm the recommended phase 2 dose.
干预措施: D-1553 (Drug)
Phase 2 of D-1553 monotherapy
Phase 1b will evaluate more subjects at the recommended phase 2 dose of D-1553 to evaluate the efficacy.
干预措施: D-1553 (Drug)
结局指标
主要结局
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: Through study completion, approximately 3 years
Overall Response Rate (ORR, Complete Response \[CR\] + Partial Response \[PR\])
Number of subjects participants with adverse events
时间窗: Through study completion, approximately 3 years
Number of subjects participants with adverse events
次要结局
- Plasma concentration of D-1553(approximately 6 months)