RE: Have we missed something?18 Aug 2023 12:01
"Let's spin this in a positive way."
The fact is, never have such high concentrations of doxorubicin been able to be targetted to a tumour, so of course it's not known whether AVA6000 may be able to keep tumours in check nor whether even higher doses may cause tumours to regress. And for those reasons, the dose is being escalated until the clinicians decide that DLT have caused the MTD to be reached.
The trial currently has been given authority to progress to a seventh cohort and a maximum dose of 400mg/m² or 3.6 times the standard 75mg/m² doxorubicin dose and 4.5 times the 60mg/m² dose. The clinicians, who are very experienced in these matters, have seen that DLTs were close so, personally, I don't see the escalation going up by 90mg/m² to that maximum should they decide to go to C7.