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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05199337
Registration number
NCT05199337
Ethics application status
Date submitted
9/01/2022
Date registered
20/01/2022
Date last updated
5/03/2024
Titles & IDs
Public title
Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
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Scientific title
A Single Arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
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Secondary ID [1]
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ZN-d5-003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Amyloidosis
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AL Amyloidosis
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Condition category
Condition code
Metabolic and Endocrine
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Other metabolic disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Metabolic and Endocrine
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Metabolic disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ZN-d5
Experimental: 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.
Treatment: Drugs: ZN-d5
ZN-d5 will be administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and Tolerability
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Assessment method [1]
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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
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Timepoint [1]
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18 Months
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Primary outcome [2]
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Dose limiting toxicities
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Assessment method [2]
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Incidence of Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects
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Timepoint [2]
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18 Months
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Secondary outcome [1]
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PK Parameter: Finding max concentration (Cmax) of ZN-d5
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Assessment method [1]
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Determine the maximum observed concentration (Cmax) of ZN-d5 collected in the plasma from subjects at different dose levels.
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Timepoint [1]
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48 months
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Secondary outcome [2]
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PK Parameter: Finding time to maximum concentration (Tmax) of ZN-d5
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Assessment method [2]
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The duration (in hours) it takes for ZN-d5 to reach the maximum concentration (or Cmax) collected in the plasma from subjects at different dose levels.
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Timepoint [2]
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48 months
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Secondary outcome [3]
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PK Parameter: Finding half-life of ZN-d5
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Assessment method [3]
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The time takes for half the drug concentration of ZN-d5 to be eliminated (Half-life) from the plasma that was collected from subjects at different dose levels
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Timepoint [3]
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48 months
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Secondary outcome [4]
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PK Parameter: Finding the Area Under the Curve (AUC) of ZN-d5
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Assessment method [4]
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The total exposure of ZN-d5 over time (AUC) from the plasma collected by the subject at different dose levels.
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Timepoint [4]
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48 months
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Secondary outcome [5]
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Assess the hematologic response to ZN-d5
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Assessment method [5]
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The number of Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), No Response (NR), Progressive Disease (PD) using the AL Amyloidosis Hematologic Response Criteria.
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Timepoint [5]
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48 months
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Secondary outcome [6]
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Duration and time to hematologic response to ZN-d5
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Assessment method [6]
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The rate of, duration of, and time to CR, modified Complete Response (mCR), CR+VGPR, and mCR+VGPR
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Timepoint [6]
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48 months
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Eligibility
Key inclusion criteria
Key
1. Diagnosis of AL amyloidosis based on histopathology, the presence of characteristic
appearance on electron microscopy, or mass spectrometry typing of amyloid.
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;
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Presence of non-AL amyloidosis, including wild-type or mutated ATTR amyloidosis;
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;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
135
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Blackwater (Westmead) Hospital - Westmead
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Recruitment hospital [2]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4102 - Brisbane
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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- Nedlands
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Colorado
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United States of America
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Louisiana
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United States of America
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Missouri
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Country [5]
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United States of America
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State/province [5]
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Tennessee
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Country [6]
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Cyprus
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State/province [6]
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Nicosia
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Country [7]
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Greece
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State/province [7]
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Athens
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Country [8]
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Israel
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Haifa
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Israel
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State/province [9]
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Jerusalem
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Israel
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Tel Aviv
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Italy
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State/province [11]
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Bologna
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Italy
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Pavia
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Country [13]
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Spain
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State/province [13]
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Badalona
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Spain
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State/province [14]
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Murcia
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Country [15]
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Spain
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State/province [15]
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Barcelona
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Country [16]
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Spain
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State/province [16]
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Salamanca
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05199337
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Affairs
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Address
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K-Group Alpha subsidiary of Zentalis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05199337
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