would a Phase III that repeats the Phase II be nec
Post# of 148087
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would a Phase III that repeats the Phase II be necessary because this trial lacks scale?
Phase 3 would use the same combo as phase 2 because the proof of effectiveness in phase 2 is a combination of those drugs. To prove what leronlimab could do alone or in combo with trifluridine/tipiracil and our effect on angiogenesis is as good as bevacizumab we would have to start off with preclinical than a phase 1.
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You also mention that this would be a fourth-line treatment. Could an oncologist prescribe this combo off-label as an earlier treatment, or is that not done?
A doctor can prescribe any approved drug off-label for any indication at any level of treatment that they think will have benefit. They will usually be more cautious on prescribing for diseases not directly related to the approval. On approval for colorectal cancer prescribing leronlimab for first line treatment along with standard of care should be no problem.