A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Combination With IN10018 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- adverse events
研究概览
简要总结
This is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor 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 solid tumor, 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 (only for phase1b) containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used.
- •Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
- •Subject has measurable disease according to RECIST, v1.1
排除标准
- •Subject with unstable or progressive central nervous system (CNS) metastases.
- •Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.
- •Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is > 480 msec based on triplicate measurements of electrocardiogram (ECG).
- •Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;
- •Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection;
- •Subject is pregnant or lactating.
研究组 & 干预措施
Phase 1b Dose escalation of D-1553 plus IN10018
Phase 1b will evaluate up sequential cohorts with different doses of IN10018 together with 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 escalation of D-1553 plus IN10018
Phase 1b will evaluate up sequential cohorts with different doses of IN10018 together with D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation.
干预措施: IN10018 (Drug)
Phase 2 Doseexpansion of D-1553 plus IN10018
Phase 2 will include more subjects to further evaluate the safety and efficacy of D-1553 in combination with IN10018 in patients with solid tumors with KRasG12C mutation.
干预措施: D-1553 (Drug)
Phase 2 Doseexpansion of D-1553 plus IN10018
Phase 2 will include more subjects to further evaluate the safety and efficacy of D-1553 in combination with IN10018 in patients with solid tumors with KRasG12C mutation.
干预措施: IN10018 (Drug)
结局指标
主要结局
adverse events
时间窗: Through study completion, approximately 3 years
Number of subjects participants with adverse events
Objective response rate (ORR) per RECIST v1.1
时间窗: Through study completion, approximately 3 years
Defined as the proportion of patients with complete response (CR) or partial response (PR).
次要结局
未报告次要终点