Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
NCT ID: NCT05199337
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2021-11-30
2024-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
Subjects will receive ZN-d5 orally (PO), once (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ZN-d5
ZN-d5 will be administered orally
Interventions
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ZN-d5
ZN-d5 will be administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Prior AL amyloidosis treatment and has received at least one, but no more than three lines of prior therapy;
3. 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;
4. Measurable disease defined by serum differential free light chain;
5. Assessment of t(11,14) status by FISH;
6. Eastern Cooperative Oncology Group performance status ≤2 ;
7. History of organ involvement
8. Adequate bone marrow function prior to first administration of study drug;
9. Adequate organ function;
Exclusion Criteria
2. Diagnosis of multiple myeloma according to the 2014 International Myeloma Working Group diagnostic criteria;
3. Mayo 2012 Stage IV disease;
4. Cardiac involvement exclusions apply to some subjects, including heart failure and cardiac arrhythmias.
5. Prior treatment with other BCL-2 inhibitors;
18 Years
ALL
No
Sponsors
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K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Affairs
Role: STUDY_DIRECTOR
K-Group Alpha subsidiary of Zentalis Pharmaceuticals
Locations
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University of Southern California
Los Angeles, California, United States
Colorado Blood Cancer Institute
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
National and Kapodistrian University of Athens
Athens, , Greece
Rambam Hospital
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Sheba Medical Center
Tel Aviv, , Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, , Israel
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, , Italy
ICO Badalona-H.U. Germans Trias i Pujol
Barcelona, Badalona, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Clinico de Salamanca
Salamanca, , Spain
Countries
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References
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Locke M, Nieto M. AL Amyloidosis: Current Treatment and Outcomes. Adv Hematol. 2025 Mar 3;2025:7280805. doi: 10.1155/ah/7280805. eCollection 2025.
Other Identifiers
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ZN-d5-003
Identifier Type: -
Identifier Source: org_study_id
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