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.
- 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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Diagnosis of AL amyloidosis based on histopathology, the presence of characteristic appearance on electron microscopy, or mass spectrometry typing of amyloid.
- Prior AL amyloidosis treatment and has received at least one, but no more than three lines of prior therapy;
- Adequate time since prior therapy before initiation of treatment (at least 3 months from hematopoietic stem cell transplantation or the shorter of 60 days or 5 half-lives for biologics, small molecules or investigational drugs);
- Measurable disease defined by serum differential free light chain;
- Assessment of t(11,14) status by FISH;
- Eastern Cooperative Oncology Group performance status ≤2 ;
- History of organ involvement
- Adequate bone marrow function prior to first administration of study drug;
- Adequate organ function;
Key Exclusion Criteria:
- Presence of non-AL amyloidosis, including wild-type or mutated ATTR amyloidosis;
- Diagnosis of multiple myeloma according to the 2014 International Myeloma Working Group diagnostic criteria;
- Mayo 2012 Stage IV disease;
- Cardiac involvement exclusions apply to some subjects, including heart failure and cardiac arrhythmias.
- Prior treatment with other BCL-2 inhibitors;
Dr. Brad Augustson
K-Group Alpha, Inc.
Phase 1 & 2