精准Precision：2025年1期肿瘤临床试验适应性设计白皮书（英文版）

For decades, the standard for first-in-human (FIH) Phase 1 oncology trials was the 3+3 dose escalation design. Originally introduced in the 1940s, this rule-based method has been widely utilized for its simplicity and robustness, providing a clear, step-by-step pathway to identifying a maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs). However, as targeted therapies, immunotherapies, and combination regimens reshape cancer care, this conventional design often fails to capt