me:
is Project Optimus about finding the effective dose
me:
is Project Optimus about finding the effective dose instead of finding the max tolerable dose and then reducing from there?
AI Overview
"Yes, Project Optimus is about shifting away from the old approach of finding the maximum tolerated dose (MTD) first and reducing it later. Instead, it aims to find an optimal dose (or optimal biological dose/range) that *balances safety and efficacy* right from the start of clinical development".
me again:
what is the leronlimab max tolerable dose?
I think what project optimus does is different than finding the leron effective dose
I dont think since leron is the safest oncology drug there is, that doing another trial to make sure they pinpoint the exact most effective dose amount happens
there is a max tolerable dose of toxic chemo drugs before it kills patients no matter where or what type cancer.
I dont think the exact effective dose for every patient for every tumor is going to apply to leron
they could spend 20 years figuring that out testing based on the various stroma densities of each tumor type
Fda
"ok, leron and 700mg in mcrc shrunk the tumor, caused tcell penetration and stopped metastasis, raised pdl1 and caused ici effectiveness, lets test 525mg for a couple years in another phase 2 and see what happens. Maybe its just as good!?"
In my opinion, not gonna happen
every other oncology drug ever tested causes toxicity
Not leron
Or ccr5 delete humans could not live.
Oh yeah
every leron dose currently tested will eventually be used to treat different disease states
there is no amount that is " just right" in every situation
They can figure it out as they go I think after approval and more physician monitoring
no other drug ever is comparable to leron
it rewrites the book
Ps. i think J used 350mg and 700mg to give the greatest separation between both effectiveness differences and to more negate the backbone contribution question
4
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