Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
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| ClinicalTrials.gov Identifier: NCT05199337 |
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Recruitment Status :
Recruiting
First Posted : January 20, 2022
Last Update Posted : May 15, 2023
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Sponsor:
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Amyloidosis AL Amyloidosis | Drug: ZN-d5 | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 135 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Single Arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis |
| Actual Study Start Date : | November 30, 2021 |
| Estimated Primary Completion Date : | May 2025 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment Arm
Subjects will receive ZN-d5 orally (PO), once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Drug: ZN-d5
ZN-d5 will be administered orally
Other Name: Study Drug |
Primary Outcome Measures :
- Safety and Tolerability [ Time Frame: 18 Months ]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
- Dose limiting toxicities [ Time Frame: 18 Months ]Incidence of Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects
Secondary Outcome Measures :
- PK Parameter: Finding max concentration (Cmax) of ZN-d5 [ Time Frame: 48 months ]Determine the maximum observed concentration (Cmax) of ZN-d5 collected in the plasma from subjects at different dose levels.
- PK Parameter: Finding time to maximum concentration (Tmax) of ZN-d5 [ Time Frame: 48 months ]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.
- PK Parameter: Finding half-life of ZN-d5 [ Time Frame: 48 months ]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
- PK Parameter: Finding the Area Under the Curve (AUC) of ZN-d5 [ Time Frame: 48 months ]The total exposure of ZN-d5 over time (AUC) from the plasma collected by the subject at different dose levels.
- Assess the hematologic response to ZN-d5 [ Time Frame: 48 months ]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.
- Duration and time to hematologic response to ZN-d5 [ Time Frame: 48 months ]The rate of, duration of, and time to CR, modified Complete Response (mCR), CR+VGPR, and mCR+VGPR
Other Outcome Measures:
- To assess potential biomarker of ZN-d5 [ Time Frame: 48 months ]The number of peripheral B-Cells from blood tests
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- 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;
- Adequate time since prior therapy before initiation of treatment (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);
- 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 Criteria:
- 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;
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05199337
Contacts
| Contact: K-Group Alpha subsidiary of Zentalis Pharmaceuticals | medicalaffairs@zentalis.com |
Locations
Show 21 study locations
Sponsors and Collaborators
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Investigators
| Study Director: | Medical Affairs | K-Group Alpha subsidiary of Zentalis Pharmaceuticals |
| Responsible Party: | K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT05199337 |
| Other Study ID Numbers: |
ZN-d5-003 |
| First Posted: | January 20, 2022 Key Record Dates |
| Last Update Posted: | May 15, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.:
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Amyloidosis AL Amyloidosis RRAL BCL2 Inhibitor |
t(11;14) ZN-d5 Light Chain Amyloidosis Light chain (AL) Amyloidosis |
Additional relevant MeSH terms:
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Immunoglobulin Light-chain Amyloidosis Amyloidosis Proteostasis Deficiencies Metabolic Diseases Neoplasms, Plasma Cell Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Paraproteinemias |