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A randomized phase II/III study of Dalotuzumab in Combination with Cetuximab and Irinotecan in Chemorefractory, KRAS Wild-Type, metastatic colorectal Cancer

doi: 10.1073/pnas.2014213117 18 Harun-Or-RashidM.InmanD

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As of 2026, no registered Phase I or Phase II trials for KPV in humans are listed on ClinicalTrials.gov.12 The FDA specifically cited the lack of human exposure data as part of its 2023 categorization decision.8 What this means practically: Efficacy signals from animal models do not automatically translate to human outcomes Long-term safety in human populations has not been established Dosing protocols remain clinical judgment calls rather than evidence-based standards Any patient considering KPV should do so under clinical supervision with baseline inflammatory marker testing These limitations do not invalidate the research