HEC169096 in Participants With Advanced Solid Tumors
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Participant's cancer has a known primary driver alteration other than RET. * Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment; * Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (w