This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid malignancies and uses a practical continuous reassessment model \[CRM\] to guide dose escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical activity of AMG 319 in this patient population.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
AMG 319 is a highly selective, orally bioavailable and potent small molecule inhibitor of PI3Kδ.
Research Site
Hackensack, New Jersey, United States
Research Site
Durham, North Carolina, United States
Research Site
Salt Lake City, Utah, United States
Clinically significant or > or = to Grade 3 CTCAE changes in safety laboratory tests, physical exams, ECGs or vital signs
Time frame: 28 Days after last subject enrolled per each cohort
PK parameters
Time frame: 28 Days after last subject enrolled per each cohort
Clinical/radiological response rate for CLL subjects
Time frame: With primary analysis
Treatment-emergent adverse events
Time frame: 28 Days after last subject enrolled per each cohort
Phospho-AKT level in circulating CLL cells
Time frame: With primary analysis
Number of patients with clinical/radiological response
Time frame: With primary analysis
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