Phase 1/2 Study of the Highly-selective RET Inhibitor,HEC169096 in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors.
• Phase 1：Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.
• Phase 2： All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor.
• Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
• Measurable or non-measurable disease as determined by RECIST 1.1;
• Adequate hematologic, hepatic and renal function;
• Life expectancy of at least 12 weeks;
• Negative pregnancy test (urine or serum) for female patients of childbearing potential;
• Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy).