Recommended phase 2 dose (RP2D) of nemvaleukin alfa in patients (pts) with advanced solid tumors treated with less frequent intravenous (IV) dosing (ARTISTRY-3).doi:10.1200/JCO.2024.42.16_suppl.2587312587#Background:Nemvaleukin alfa (nemvaleukin, ALKS 4230) is a novel engineered cytokine...
因此研究人员选用260 mg/m2作为RP2D。 A phase I/II dose-escalation study investigating all-oral ixazomib melphalanprednisone induction followed by single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma复制标题 一项I/II期剂量递增研究,调查全口服ixazomib melphalan泼尼松诱导...
Clinical pharmacokinetics (PK) and translational PK- pharmacodynamic (PD) modeling and simulation to predict antitumor response of various dosing schedules to guide the selection of a recommended phase II dose (RP2D) and schedule for the ... Chirag G. Patel,M Patel,A Chakravarty,... - 《Journ...
SC administration has permitted higher doses than could be achieved with IV treatment, however, at the higher dose range, CRS was observed. Even though the MTD was 4mg/m2, given the responses, AEs, and biologic activity in the Phase I study, the RP2D was determined to be 2mg/m2. ...
dose of 3 mg/kg and 5 mg/kg respectively; in addition, another subject with advanced melanoma achieved SD with 20% tumor size shrinkage at 2 mg/kg dose level. After reviewed clinical data, the Safety Review Committee (SRC) unanimously agreed that 5mg/kg Q3W should be RP2D used as ...
The maximum tolerated dose was defined as the highest dose level at which < 33% of pts experienced a dose-limiting toxicity (DLT) during Cycle 1. The primary objective, determination of the abemaciclib RP2D, was defined based on the totality of safety, tolerability, and pharmacokinetic (PK) ...
Safety and recommended phase II dose (RP2D) of the selective oral MEK1/2 inhibitor pimasertib (MSC1936369B/AS703026): results of a phase I trial. Eur J Cancer. 2012;48:6185-6186 (abstract 604).A. Awada,J.P. Delord,N. Houédé,C. Lebbe,T. Lesimple,J.H.M. Schellens,S. ...
The dose‐escalation phase evaluated the recommended phase II dose (RP2D; primary endpoint). The expansion phase evaluated overall response rate (primary end point) at the RP2D in patients with triple‐negative breast cancer (TNBC). During dose‐escalation (n = 24), two dose‐limit...
Another patient at the 0.09 mg/kg dose level, previously treated with osimertinib, has stable disease and is continuing treatment after 9 cycles.Conclusions:There was 1 PR with quaratusugene ozeplasmid and osimertinib combination therapy in the 8 patients enrolled in the Phase 1 dose escalation, ...
Novel Semi-Mechanistic Model Leveraging Preclinical and Clinical Data to Inform the Recommended Phase 2 Dose (RP2D) Selection for Epcoritamab (DuoBody CD3xCD20) - ScienceDirectTommy Li PhD *Ida H Hiemstra PhD *Christopher Chiu PhD *Roberto S Oliveri MD PhD *...