RE: AVA6000 trial details4 Mar 2022 15:28
Thanks for posting and the reminder.
I noticed the following... 'Patients in Phase Ia will receive escalating doses of AVA6000 following a 3+3 design, commencing with a starting dose of 80mg/m2, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first'
'reaching maximum lifetime cumulative exposure to doxorubicin'. Do we know how this will be measured? Will it consider the cumulative toxic effect in the heart or is it just measured with a calculator i.e. as simple as the cumulative total of the doses given? If the latter, then that suggests that this trial won't be considering the potential to increase this limit. Due to the targetting nature of AVA, I'd hope this would be a possibility - via a separate trial? Perhaps it won't be needed, the mice results suggested a concentration of 3x in the tumour. If the cancer is taken care of before reaching the limit then there's no need to think about changing it :-)