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.

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;
• 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 prior to starting treatment;
• 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;