CompletedPhase 1/2

Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis

United States18 participantsStarted 2021-11-30

Plain-language 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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;

Safety and Tolerability

Timeframe: 18 Months

Dose limiting toxicities

Timeframe: 18 Months

NCT IDNCT05199337

SponsorK-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-14

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;