{"entity":{"id":"rp2d","kind":"term","name":"Recommended phase 2 dose (RP2D)","aka":["RP2D","recommended phase 2 dose","recommended phase II dose","recommended dose","recommended dose for expansion","dose selected","selected dose","the dose taken forward","registrational dose"],"tldr":"The dose and schedule chosen at the end of a phase 1 trial to test in larger trials, based on safety, blood levels and early signs of activity. It is often, but no longer always, the maximum tolerated dose.","summary":"Choosing the RP2D integrates dose-limiting toxicities, pharmacokinetics (whether exposure plateaus), pharmacodynamic target engagement, and responses across dose levels; expansion cohorts then test it in specific tumour types. Because the RP2D usually becomes the approved dose, errors are expensive: too high causes discontinuations and dose reductions in practice, too low wastes efficacy. Under Project Optimus, sponsors are expected to compare two or more doses in randomised cohorts before selecting the RP2D, and to report the proportion of patients needing reductions. Dose changes after approval (via label updates) are increasingly common.","asOf":"2026-09-09","wikipedia":"https://en.wikipedia.org/wiki/Phase_I_clinical_trial","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Phase_I_clinical_trial"}],"tags":[],"related":["mtd","dose-limiting-toxicity","dose-escalation-design","pharmacokinetics"],"cancers":[],"sections":["drug-discovery"],"technologies":["project-optimus"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Trials"},"route":"/terms/rp2d/","neighbours":{"term":[{"id":"dose-escalation-design","kind":"term","name":"Dose-escalation designs (3+3, BOIN, dose-expansion)","route":"/terms/dose-escalation-design/"},{"id":"dose-limiting-toxicity","kind":"term","name":"Dose-limiting toxicity (DLT)","route":"/terms/dose-limiting-toxicity/"},{"id":"mtd","kind":"term","name":"Maximum tolerated dose (MTD)","route":"/terms/mtd/"},{"id":"pharmacokinetics","kind":"term","name":"Pharmacokinetics (PK), half-life and exposure","route":"/terms/pharmacokinetics/"},{"id":"project-optimus","kind":"term","name":"Project Optimus","route":"/terms/project-optimus/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}],"drug":[{"id":"ivermectin","kind":"drug","name":"Ivermectin","route":"/drugs/ivermectin/"},{"id":"mebendazole","kind":"drug","name":"Mebendazole","route":"/drugs/mebendazole/"}],"trial":[{"id":"nct05318469","kind":"trial","name":"Ivermectin with balstilimab or pembrolizumab in metastatic triple-negative breast cancer (Cedars-Sinai phase 1/2)","route":"/trials/nct05318469/"}],"paper":[{"id":"paper-patil-mebendazole-glioma-phase-1-cancer-med-2020","kind":"paper","name":"Reverse swing-M, phase 1 study of repurposing mebendazole in recurrent high-grade glioma","route":"/key-papers/paper-patil-mebendazole-glioma-phase-1-cancer-med-2020/"}]}}