"Phase 1b, Dose-Escalation (Lead-in Stage)
A two-cohort dose escalation schema using a 3 + 3 design will be employed.
Cohort 1 will enroll three subjects to receive the FluCloXan regimen for four consecutive days. If no dose limiting toxicities (DLTs) have occurred in the first three subjects by day 30 of their first cycle of treatment, then dose escalation to Cohort 2 will occur."
They aren't waiting to check the efficacy. They are ensuring there are no dose limiting toxicities before moving on.
"Phase 1b, Dose-Escalation (Lead-in Stage) A two-cohort dose...
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