ZN-d5 for AL Amyloidosis

Recruiting in Palo Alto (17 mi)

+40 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called ZN-d5 for patients with Light Chain (AL) Amyloidosis whose condition has come back or did not respond to other treatments. The drug aims to reduce harmful protein production in the body.

Eligibility Criteria

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.

Inclusion Criteria

My bone marrow is functioning well enough for treatment.

My cancer has been tested for the t(11,14) genetic change.

I can take care of myself but might not be able to do heavy physical work.

I have been diagnosed with AL amyloidosis through tissue testing.

Exclusion Criteria

My condition is non-AL amyloidosis, including wild-type or mutated ATTR.

I have been treated with BCL-2 inhibitors before.

My condition is classified as Stage IV according to Mayo 2012.

I have been diagnosed with multiple myeloma.

Participant Groups

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.

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.