Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis

Last updated: September 12, 2024
Sponsor: K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1/2

Condition

Amyloidosis

Treatment

ZN-d5

Clinical Study ID

NCT05199337
ZN-d5-003
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Diagnosis of AL amyloidosis based on histopathology, the presence of characteristicappearance on electron microscopy, or mass spectrometry typing of amyloid.

  2. Prior AL amyloidosis treatment and has received at least one, but no more than threelines of prior therapy;

  3. At least 3 months from hematopoietic stem cell transplantation or the shorter of 60days or 5 half-lives for biologics, small molecules, or investigational drugs priorto 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;

Exclusion

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 WorkingGroup diagnostic criteria;

  3. Mayo 2012 Stage IV disease;

  4. Cardiac involvement exclusions apply to some subjects, including heart failure andcardiac arrhythmias.

  5. Prior treatment with other BCL-2 inhibitors;

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: ZN-d5
Phase: 1/2
Study Start date:
November 30, 2021
Estimated Completion Date:
February 14, 2024

Study Description

A Single Arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis. The first part of the study is phase 1 dose-escalation and the second part will be phase 2.

Connect with a study center

  • Blackwater (Westmead) Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Site 2711

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Site 2712

    Brisbane, Queensland 4102
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Site 2714

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia
    Australia

    Site Not Available

  • Site 2713

    Nedlands, Western Australia
    Australia

    Active - Recruiting

  • Bank of Cyprus Hospital

    Nicosia,
    Cyprus

    Site Not Available

  • Site 4202

    Nicosia,
    Cyprus

    Active - Recruiting

  • National and Kapodistrian University of Athens

    Athens, 115 28
    Greece

    Site Not Available

  • Site 4101

    Athens, 115 28
    Greece

    Active - Recruiting

  • Rambam Hospital

    Haifa, 3109601
    Israel

    Site Not Available

  • Site 3804

    Haifa,
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem,
    Israel

    Site Not Available

  • Site 3805

    Jerusalem,
    Israel

    Active - Recruiting

  • Site 3802

    Ramat Gan,
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel Aviv,
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv,
    Israel

    Site Not Available

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi

    Bologna,
    Italy

    Site Not Available

  • Site 3302

    Bologna,
    Italy

    Active - Recruiting

  • Fondazione I.R.C.C.S. Policlinico San Matteo

    Pavia,
    Italy

    Site Not Available

  • Site 3201

    Pavia,
    Italy

    Active - Recruiting

  • ICO Badalona-H.U. Germans Trias i Pujol

    Barcelona, Badalona
    Spain

    Site Not Available

  • Site 3502

    Barcelona, Badalona
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia 30120
    Spain

    Site Not Available

  • Site 3507

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Site 3509

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Clinico de Salamanca

    Salamanca,
    Spain

    Site Not Available

  • Site 3506

    Salamanca,
    Spain

    Active - Recruiting

  • Site 0203

    Los Angeles, California 90089
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90089
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Site 0198

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Site 0200

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Tulane University

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Site 2404

    Saint Louis, Missouri 63130
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Site 0199

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.