This is a single arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis.
A Single Arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis. The first part of the study is phase 1 dose-escalation and the second part will be phase 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
ZN-d5 will be administered orally
University of Southern California
Los Angeles, California, United States
Colorado Blood Cancer Institute
Safety and Tolerability
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: 18 Months
Dose limiting toxicities
Incidence of Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects
Time frame: 18 Months
PK Parameter: Finding max concentration (Cmax) of ZN-d5
Determine the maximum observed concentration (Cmax) of ZN-d5 collected in the plasma from subjects at different dose levels.
Time frame: 48 months
PK Parameter: Finding time to maximum concentration (Tmax) of ZN-d5
The duration (in hours) it takes for ZN-d5 to reach the maximum concentration (or Cmax) collected in the plasma from subjects at different dose levels.
Time frame: 48 months
PK Parameter: Finding half-life of ZN-d5
The time takes for half the drug concentration of ZN-d5 to be eliminated (Half-life) from the plasma that was collected from subjects at different dose levels
Time frame: 48 months
PK Parameter: Finding the Area Under the Curve (AUC) of ZN-d5
The total exposure of ZN-d5 over time (AUC) from the plasma collected by the subject at different dose levels.
Time frame: 48 months
Assess the hematologic response to ZN-d5
The number of Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), No Response (NR), Progressive Disease (PD) using the AL Amyloidosis Hematologic Response Criteria.
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Denver, Colorado, United States
Tulane University
New Orleans, Louisiana, United States
Washington University
St Louis, Missouri, United States
Tennessee Oncology
Nashville, Tennessee, United States
Blackwater (Westmead) Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Bank of Cyprus Hospital
Nicosia, Cyprus
...and 11 more locations
Time frame: 48 months
Duration and time to hematologic response to ZN-d5
The rate of, duration of, and time to CR, modified Complete Response (mCR), CR+VGPR, and mCR+VGPR
Time frame: 48 months