P1aA2 Q2W dosing28 Feb 2024 13:40
Afternoon Ice, hope all good.
I’ve gone through the slide decks of recent presentations from Avacta. I think I’ve found the answer to your question about the P1aA2 Q2W dosing trial.
Though plain doxorubicin is a licensed first line treatment for STS, it isn’t actually that effective with its present dosing regime. Looking at the slides it appears Avacta have looked at the data from a STS patient receiving AVA6000 and the rest of their data. From this they’ve extrapolated that Q2W dosing is the optimal regime. They want to drive up the doxorubicin level far higher than the present limits imposed by the Q3W dosing regime of plain doxorubicin.
The Q2W trial will establish safety, start assessment of efficacy, and help determine the MTD or RP2D for the P2 trial. It doesn’t appear to be FDA driven. But good reasons to do it. This also touches on Touk’s comments about cleaving rate of free doxorubicin from AVA6000 by FAP.
GLA.