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
1 other identifier
interventional
18
7 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2021
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2021
CompletedFirst Submitted
Initial submission to the registry
January 9, 2022
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2024
CompletedSeptember 19, 2024
September 1, 2024
2.2 years
January 9, 2022
September 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and Tolerability
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
18 Months
Dose limiting toxicities
Incidence of Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects
18 Months
Secondary Outcomes (6)
PK Parameter: Finding max concentration (Cmax) of ZN-d5
48 months
PK Parameter: Finding time to maximum concentration (Tmax) of ZN-d5
48 months
PK Parameter: Finding half-life of ZN-d5
48 months
PK Parameter: Finding the Area Under the Curve (AUC) of ZN-d5
48 months
Assess the hematologic response to ZN-d5
48 months
- +1 more secondary outcomes
Other Outcomes (1)
To assess potential biomarker of ZN-d5
48 months
Study Arms (1)
Treatment Arm
EXPERIMENTALSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- Prior treatment with other BCL-2 inhibitors;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
University of Southern California
Los Angeles, California, 90089, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Washington University
St Louis, Missouri, 63130, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Blackwater (Westmead) Hospital
Westmead, New South Wales, 2145, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Bank of Cyprus Hospital
Nicosia, Cyprus
National and Kapodistrian University of Athens
Athens, 115 28, Greece
Rambam Hospital
Haifa, 3109601, 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, 30120, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Clinico de Salamanca
Salamanca, Spain
Related Publications (1)
Locke M, Nieto M. AL Amyloidosis: Current Treatment and Outcomes. Adv Hematol. 2025 Mar 3;2025:7280805. doi: 10.1155/ah/7280805. eCollection 2025.
PMID: 40226119DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Affairs
K-Group Alpha subsidiary of Zentalis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2022
First Posted
January 20, 2022
Study Start
November 30, 2021
Primary Completion
February 14, 2024
Study Completion
February 14, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share