From Cydy fda approval mcrc announcement
"TAS-102 and bevacizumab will be administered for three of four weeks in a four-week cycle, and leronlimab (at doses of 350 mg or 700 mg) will be administered weekly.
**The study will include a safety lead-in treating five patients in the 350 mg leronlimab arm prior to beginning enrollment to the 700 mg leronlimab arm**
Where does the 20 patient dsmb look in before escalating to 700mg come from?
Is there a later change in process in another announcement?
https://www.cytodyn.com/newsroom/detail/623/c...n-phase-ii
"TAS-102 and bevacizumab will be administered for three of four weeks in a four-week cycle, and leronlimab (at doses of 350 mg or 700 mg) will be administered weekly.
**The study will include a safety lead-in treating five patients in the 350 mg leronlimab arm prior to beginning enrollment to the 700 mg leronlimab arm**
Where does the 20 patient dsmb look in before escalating to 700mg come from?
Is there a later change in process in another announcement?
https://www.cytodyn.com/newsroom/detail/623/c...n-phase-ii
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