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ZN-d5 for AL Amyloidosis

Phase 1 & 2
Waitlist Available
Research Sponsored by K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior AL amyloidosis treatment and has received at least one, but no more than three lines of prior therapy
Adequate bone marrow function prior to first administration of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study Summary

This trial is testing a new drug for people with a specific type of blood cancer that has come back or doesn't respond to treatment.

Who is the study for?
This trial is for adults with AL Amyloidosis who have tried treatments before but are still sick. They should be fairly active (able to care for themselves), have decent bone marrow function, and no heart failure or serious arrhythmias. People can't join if they've had more than three prior therapies, other types of amyloidosis like ATTR, or a diagnosis of multiple myeloma.Check my eligibility
What is being tested?
The study tests ZN-d5 on its own in people whose AL Amyloidosis has come back or didn't respond to treatment. It's an early-stage trial (Phase 1/2) where everyone gets the same experimental drug to see how safe it is and if it works against this disease.See study design
What are the potential side effects?
Since ZN-d5 is new and being tested, side effects aren't fully known yet. However, similar drugs often cause nausea, fatigue, low blood counts that can lead to infections or bleeding problems, and sometimes liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had 1 to 3 treatments for AL amyloidosis.
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My bone marrow is functioning well enough for treatment.
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It's been over 3 months since my last major treatment or enough time for previous drugs to leave my system.
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My organs have been affected by my condition.
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My cancer has been tested for the t(11,14) genetic change.
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I can take care of myself but might not be able to do heavy physical work.
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I have been diagnosed with AL amyloidosis through tissue testing.
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My organs are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities
Safety and Tolerability
Secondary outcome measures
Assess the hematologic response to ZN-d5
Duration and time to hematologic response to ZN-d5
PK Parameter: Finding half-life of ZN-d5
+3 more
Other outcome measures
Zinc

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
226 Total Patients Enrolled
K-Group Alpha, Inc.Lead Sponsor
2 Previous Clinical Trials
131 Total Patients Enrolled
Medical AffairsStudy DirectorK-Group Alpha subsidiary of Zentalis Pharmaceuticals
39 Previous Clinical Trials
8,425 Total Patients Enrolled

Media Library

ZN-d5 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05199337 — Phase 1 & 2
Amyloidosis Research Study Groups: Treatment Arm
Amyloidosis Clinical Trial 2023: ZN-d5 Highlights & Side Effects. Trial Name: NCT05199337 — Phase 1 & 2
ZN-d5 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05199337 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical sites are currently executing this clinical experiment?

"Currently, 4 sites are running this clinical trial. These include locations in New Orleans, Nashville and Denver alongside an additional 4 cities. To keep travel to a minimum, it is advised that participants select the site closest to them for enrollment."

Answered by AI

What goals are researchers striving to achieve by conducting this investigation?

"The primary outcome of this 18 month trial is to evaluate the safety and tolerability. Additionally, researchers will assess hematologic response to ZN-d5 by quantifying complete responses (CR), very good partial responses (VGPR), partial responses (PR) or no response/progressive disease (NR/PD). Duration and time to a CR+VGPR or mCR+ VGPR must also be recorded while measuring half life of ZN-d5 in plasma samples from different dose levels."

Answered by AI

Is recruitment for this medical experiment still ongoing?

"Per the clinicaltrials.gov entry, this scientific experiment is still seeking participants as of October 4th 2022 - having initially been posted on November 30th 2021."

Answered by AI

What is the upper limit of participants for this research study?

"This study necessitates 135 participants meeting its inclusion criteria, with enrolment being conducted at sites such as Site 0200 in New Orleans and Site 0199 in Nashville."

Answered by AI
~43 spots leftby May 2025