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...
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...
Methods: In the SPd arm of the multi-arm Phase 1b/2 STOMP study, SEL was evaluated at 60, 80, or 100 mg QW or 60 or 80 mg twice weekly in combination with Pd. Study objectives were to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and assess the ...
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. ...
The first patient was dosed in June 2022. The Phase I dose escalation trial of the IMM27M for solid tumors is progressing smoothly. Overall data showed that IMM27M was well tolerated, without dose-limiting toxicities (DLTs) occurring in all subjects across the seven dose groups of 0.1 mg/...
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. ...
(2010). Predictors for establishing recom- mended phase 2 doses: Analysis of 320 dose-seeking oncology phase 1 trials. Investigational New Drugs, 30, 653-661. doi:10.1007/ s10637-010-9574-4Penel N, Duhamel A, Adenis A, Devos P, Isambert N, Clisant S, Bonneterre J. Predictors for ...
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, ...
The goal of the analyses reported here was to identify the recommended Phase 2 dose (RP2D) based on both tolerability and efficacy in patients with heavily pretreated hematological malignancies. Methods: A subset (N=157) of the Phase 1 patient population received oral selinexor twice weekly (8 ...