Status:
COMPLETED
Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
Lead Sponsor:
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Conditions:
Amyloidosis
AL Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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;
Key Trial Info
Start Date :
November 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05199337
Start Date
November 30 2021
End Date
February 14 2024
Last Update
September 19 2024
Active Locations (21)
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1
University of Southern California
Los Angeles, California, United States, 90089
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
3
Tulane University
New Orleans, Louisiana, United States, 70112
4
Washington University
St Louis, Missouri, United States, 63130