David S. Hong

David S. Hong, MD is Deputy Chair of the Department of Investigational Cancer Therapeutics (Phase I Program) and Professor at MD Anderson Cancer Center, where he is one of the world's foremost phase I oncologists with a career spanning hundreds of first-in-human and early-phase trials. Dr. Hong is best known internationally for leading the pivotal first-in-human clinical studies of TRK (NTRK) inhibitors and RET inhibitors — landmark trials that directly led to the first FDA tissue-agnostic drug approvals in oncology history. He was the principal investigator of the LOXO-TRK-14001 first-in-human trial of larotrectinib, which enrolled patients with TRK fusion-positive solid tumors regardless of histology and demonstrated an ORR exceeding 75%, directly enabling the FDA approval of larotrectinib in 2018 as the second-ever tissue-agnostic cancer therapy. He subsequently led LIBRETTO-001, the first-in-human phase I/II trial of selpercatinib (LOXO-292), demonstrating remarkable efficacy in RET fusion-positive lung cancers, RET-mutant thyroid cancers, and other RET-altered tumors with ORRs of 64–85% and leading to FDA approval in 2020. Dr. Hong has also led early-phase trials of novel IO combinations, KRAS G12C inhibitors, SOS1 inhibitors, and a wide range of ADCs and bispecific antibodies, making him a central figure in contemporary targeted oncology drug development. He has authored over 500 peer-reviewed publications and consistently ranks among the most cited phase I oncologists globally.