A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of NHWD-870 HCl in Patients with Lymphoma and Other Advanced Solid Tumors
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M Yin, X Li, Z Ye, J Deng, M Zhang, Z Li…
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pubmed.ncbi.nlm.nih.gov
Introduction NHWD-870 HCl is a next-generation oral BET inhibitor (US Patent 10,428,071 B2). We conducted a Phase I dose‑escalation study. Methods This multicenter, open-label, phase I study used a Bayesian optimal interval (BOIN) dose-escalation design. NHWD-870 HCl was administered once daily on an intermittent schedule (5 days on/2 days off) at doses ranging from 0.5 to 3.5 mg. The primary endpoints were safety, cycle 1 Dose-Limiting Toxicities (DLTs), the maximum tolerated dose (MTD), and the recommended phase II dose …
