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. 2020 Oct 28;14(2):536–543. doi: 10.1111/cts.12902

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© 2020 Tango Therapeutics. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

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Potency‐guided first‐in‐human trial design, including theoretical outcomes. Dose expansion is initiated at dose level 2 when the steady‐state concentration (C_ss) value is 2‐fold greater than the half‐maximal inhibitory concentration (IC₅₀) with no DLTs and 1 PR. Dose expansion is also initiated at dose levels 4 and 5 (the maximum tolerated dose (MTD)). Comparison of the first 10 patients in the 3 expansion cohorts suggests dose level 4 is most promising and further enrollment is limited to dose level 4. Dose levels 3 is not selected for expansion as exposure is overlapping, due to pharmacokinetic variability, with adjacent dose levels. Blue arrows represent enrollment into dose expansion cohorts. DLT, dose limiting toxicity; PR, partial response; RP2D, recommended phase 2 dose.