MKC-1106 / MannKind - LARVOL DELTA

Phase I study of continuous MKC-1 in patients with advanced or metastatic solid malignancies using the modified Time-to-Event Continual Reassessment Method (TITE-CRM) dose escalation design (Invest New Drugs) -

P1, N=24; Median time on drug was 8 weeks (range 4-28);  DLT occurred at 320 mg (G3 fatigue); Stable disease occurred at 150 mg/d (28 weeks; RCC) & 320 mg/d (16 weeks; breast, parotid); Escalation halted at 320 mg/d; Day 28 pharmacokinetics indicated absorption & active metabolites;

P1 data • Oncology