Is it a reasonable assumption on my part that the
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Posted On: 10/01/2025 10:29:44 PM
Is it a reasonable assumption on my part that the first 5 patients in mssCRC will be on 350mg. Then after DSMB agrees that 350mg is safe, all other 55 patients once enrolled will be randomized between 2 arms, 350mg and 700mg? I think so, but perhaps I’m as naive as I think I am.
If so we’re pretty close to an understanding of benefit from 700mg dosing. Tracking PD-L1 for instance?
“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.”
https://www.cytodyn.com/newsroom/detail/623/c...n-phase-ii
“This study will enroll approximately 60 participants, 30 participants in each of two arms evaluating either 350 mg or 700 mg of leronlimab, who are 18 years of age or older, with histologically confirmed metastatic colorectal cancer that is microsatellite stable (MSS) and CCR5+ (confirmed by an immunohistochemistry (IHC) assay). Participants will be randomized 1:1 to each arm, where approximately 30 participants will receive 350 mg of leronlimab + trifluridine and tipiracil + bevacizumab and approximately 30 will receive 700 mg of leronlimab + trifluridine and tipiracil + bevacizumab.”
https://www.clinicaltrials.gov/study/NCT06699836
If so we’re pretty close to an understanding of benefit from 700mg dosing. Tracking PD-L1 for instance?
“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.”
https://www.cytodyn.com/newsroom/detail/623/c...n-phase-ii
“This study will enroll approximately 60 participants, 30 participants in each of two arms evaluating either 350 mg or 700 mg of leronlimab, who are 18 years of age or older, with histologically confirmed metastatic colorectal cancer that is microsatellite stable (MSS) and CCR5+ (confirmed by an immunohistochemistry (IHC) assay). Participants will be randomized 1:1 to each arm, where approximately 30 participants will receive 350 mg of leronlimab + trifluridine and tipiracil + bevacizumab and approximately 30 will receive 700 mg of leronlimab + trifluridine and tipiracil + bevacizumab.”
https://www.clinicaltrials.gov/study/NCT06699836
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