A review of dose escalation for FDA-approved products treating solid tumors and hematological malignancies in first-in-human trials

Zehui Jiang, Wenxuan Sun, Rui Du,Rui Yang

Clinical and Translational Oncology（2024）

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摘要

First-in-human (FIH) dose-escalation trials on oncology should prioritize safety and emphasize efficacy. We reviewed the FIH trials of 67 anti-tumor products approved by the Food and Drug Administration between 2018 and 2023 and found that the “3 + 3” design remains the predominant dose-escalation method (66.2

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关键词

Dose escalation,First-in-human,New Drug Application,Biologics License Application,Phase I clinical trial

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