A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies

Official Title

A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignancies

Summary:

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.

Trial Description

Primary Outcome:

• Subject incidence of adverse events (AEs) as a measure of safety
• Subject incidence of dose-limiting toxicities (DLTs) as a measure of safety

• Incidence of anti-AMG 330 antibody formation
• Efficacy parameter: Response rate in subjects with relapsed/refractory acute myeloid leukemia
• Efficacy parameter: Response rate in subjects with myelodysplastic syndrome
• Efficacy parameter: Response rate in subjects with minimal residual disease (MRD) positive acute myeloid leukemia
• Efficacy parameter: Duration of response
• Efficacy parameter: Time to progression
• Efficacy parameter: Time to response
• Pharmacokinetic parameter: Half-life of AMG 330
• Pharmacokinetic parameter: Steady state concentration of AMG 330
• Pharmacokinetic parameter: Volume of distribution of AMG 330
• Pharmacokinetic parameter: Clearance of AMG 330

View this trial on ClinicalTrials.gov