RE: Cohort V Dosage5 Apr 2023 08:59
I've got to say I was expecting a bigger DE and a broader 'change' to the trial protocol, whatever that change is (nothing is showing on the trials website yet).
Firstly, if Avacta are going for only 2 more cohorts to actually find MTD then C6 would be something like 300mg/m² or, as Myles said, 312.5mg/m² which is 211mg/m² doxorubicin, or 3.5 times the standard 60mg/m² dose or 2.8 times the standard 75mg/m² dose. Still very high but I was hoping for even higher for a MTD as the higher the MTD, the greater the dosing regimen options for different cancers.
Secondly, the RNS mentions only MHRA and Phase 1a criteria. If it has taken AT LEAST ten weeks to get just MHRA approval for this change, I sincerely hope that the request for the very substantial change to Phase 1b was submitted at the same time to the MHRA, FDA and, if Europe means additional to the UK, EMA!