I was looking at this over the weekend. Doesn't the following suggest that the preliminary data (yet to be disclosed) are promising enough to have already refined the Dose Expansion Design for Phase 2 and the number of recruitments? Was there an early response to the lowest proposed dose level (or a safety issue early on) to warrant testing a dose lower than Level 1? Either way, it seems to have confirmed the higher levels as being in the optimal range, IMO. It also suggests that the possibility of increasing the Ph 1 recruitment numbers to a 5 + 5 design is no longer on the agenda. Is this your interpretation, abitlikeme?
The "Simon 2-Stage Design" for Phase 2 appears to be commonly employed. It not only allows the investigators to terminate a trial at any stage due to lack of efficacy but it reduces patient recruitment to the optimal number based on a data analysis formula, thus decreasing costs to what is necessary.
https://www.statsols.com/articles/simons-two-stage-design explains with a video too.
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