RE:RE:RE:RE:RE:RE:RE:RE:Dose Escalation Question As per the company the study will use a modified rapid dose-escalation design as described by Simon et al. (1997). Looking through the article below they might stay with one patient only (not traditional 3+3 escalation design), doubling the dose until the patient shows DLT, which can reduce the duration of the trial etc.
“Design 1 was a conventional design (similar to the commonly used modified Fibonacci method) using cohorts of three to six patients, with 40% dose-step increments and no intrapatient dose escalation. Designs 2 through 4 included only one patient per cohort until one patient experienced(DLT) dose-limiting toxic effects or two patients experienced grade 2 toxic effects (during their first course of treatment for designs 2 and 3 or during any course of treatment for design 4). Designs 3 and 4 used 100% dose steps during this initial accelerated phase.
The new designs described here appear to accomplish several objectives. They reduce the number of patients potentially undertreated. Some of these designs also reduce the duration of trials by doubling the dose until toxicity develops. These approaches also improve the information yield of phase I trials. They provide for estimation of the population distribution of the MTD and may also provide a statistical estimate of the degree of cumulative toxicity.”
https://brb.nci.nih.gov/techreport/AcceleratedTitration.pdf