"Initial Phase 1b monotherapy data for ORIC-944 in metastatic prostate cancer demonstrates potential best-in-class profile, including half-life >10 hours, robust target engagement and well tolerated safety profile, supporting advancement for combination development"
ORIC-944: for mCRPC and neuroendocrine - Advanced Prostate...
ORIC-944: for mCRPC and neuroendocrine
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Purpose
In this study, researchers want to find the highest dose of the investigational drug ORIC-944 that can be given safely in people with metastatic prostate cancer that continues to grow despite standard treatments. ORIC-944 works by blocking a group of proteins called PRC2, which promote prostate cancer growth. It is taken orally (by mouth).
Detailed Description
ORIC-944 is a potent, highly selective, allosteric, orally bioavailable, small molecule inhibitor of PRC2 via binding the embryonic ectoderm development (EED) subunit.
This is a first-in-human, open-label, single arm, multicenter, dose escalation followed by dose expansion study to establish the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) and preliminary antitumor activity of ORIC-944 in patients with metastatic prostate cancer, including those with neuroendocrine and/or small cell features, who have exhausted available treatment options.
The study will begin with dose finding in patients with metastatic prostate cancer (Dose Escalation); additional dose expansion cohorts (Dose Expansion), with specific histology, treatment history, and/or expression of a specific biomarker, may be initiated via protocol amendment The study will evaluate escalating dose levels of ORIC-944 administered orally, once daily in 28-day cycles following an interval 3+3 design.
Has anyone hear done this trial? We are considering it.