RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FittingThe part 1 phase 1 has apparently 20 patients and part 2 40 additional patients versus most likely 200 or more patients in phase 2 and more patients in phase 3. Although the primary endpoint for phase 1 is safety that's the phase will least amount of patients therefore pumping patients with extremely high dosage can back fire as the risks for grade 3 or above toxicity will increase during larger phases with more patients jeopardizing the whole trial.
They need to balance safety and efficacy from the beginning. If they don't get any DLT in the first two patients after 7 cycles then they take that dose to 3+3 escalation so that would extend the trial time but that also would be the ultimately good start. Remember project Optimus by FDA? Drug companies now are willing to produce drugs well below MTD due to adverse effects which is a lesser concern for targeted drug delivery with potentially better safety profile but that argument still is relevant for PDCs.