A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies
Study Details
The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose and/or a biologically active dose. The study will be conducted in multiple sites and test increasing doses of AMG 330. The safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.
Protocol Summary
Subject incidence of adverse events (AEs) as a measure of safety
Timeframe: 36 months
Subject incidence of dose-limiting toxicities (DLTs) as a measure of safety
Timeframe: 36 months
Incidence of anti-AMG 330 antibody formation
Timeframe: 36 months
Efficacy parameter: Response rate in subjects with relapsed/refractory acute myeloid leukemia
Timeframe: 36 months
Efficacy parameter: Response rate in subjects with myelodysplastic syndrome
Timeframe: 36 months
Efficacy parameter: Response rate in subjects with minimal residual disease (MRD) positive acute myeloid leukemia
Timeframe: 36 months
Efficacy parameter: Duration of response
Timeframe: 36 months
Efficacy parameter: Time to progression
Timeframe: 36 months
Efficacy parameter: Time to response
Timeframe: 36 months
Pharmacokinetic parameter: Half-life of AMG 330
Timeframe: 32 months
Pharmacokinetic parameter: Steady state concentration of AMG 330
Timeframe: 32 months
Pharmacokinetic parameter: Volume of distribution of AMG 330
Timeframe: 32 months
Pharmacokinetic parameter: Clearance of AMG 330
Timeframe: 32 months