Study to Evaluate Adverse Events and Movement of Intravenously (IV) Infused ABBV-787 in Adult Participants With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

Last updated: March 4, 2025
Sponsor: AbbVie
Overall Status: Terminated

Phase

1

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

ABBV-787

Clinical Study ID

NCT06068868
M23-477
2023-505233-27-00
  • Ages > 18
  • All Genders

Study Summary

Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults. This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). Adverse events and maximum tolerated dose (MTD) of ABBV-787 will be assessed.

ABBV-787 is an investigational drug being developed for the treatment of AML. Participants will receive ABBV-787 in escalating doses until the maximum tolerated dose (MTD) is determined. Approximately 60 adult participants with a diagnosis of AML will be enrolled worldwide.

Participants will receive intravenous (IV) infusions of ABBV-787 during the approximately 3 year duration a participant is followed.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • Laboratory Criteria matching those outlined in the protocol.

  • QT interval corrected for heart rate (QTc) <= 470 msec using Fridericia'scorrection, and no other clinically significant cardiac abnormalities.

  • Documented diagnosis of non-promyelocytic acute myeloid leukemia (AML), per 2022European Leukemia Net (ELN) criteria.

  • Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) who havebeen treated with up to 3 prior lines of therapy and are refractory to or intolerantof all established AML therapies that are known to clearly provide clinical benefitat the judgement of the investigator.

  • Must have a white blood cell (WBC) count < 25 × 10^9 /L prior to initiation of studydrug (Note: Hydroxyurea or leukapheresis is permitted to meet this criterion and foruse through Cycle 3 to control for hyperleukocytosis.).

Exclusion

Exclusion Criteria:

  • Have received a CD33-targeting therapy within 3 months prior to the first dose ofABBV-787.

  • Stem cell transplant within 3 months prior to first dose of study drug.

  • Have received anticancer therapy including chemotherapy, radiation therapy,immunotherapy, biologic, or any investigational therapy within 14 days or 5half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-787.

  • History of documented pneumonitis that required treatment with systemic steroidswithin the last 6 months, nor any evidence of active pneumonitis.

  • Unresolved toxicity of Grade >= 2 from prior anticancer therapy, or to levelsdictated in the eligibility criteria, with the exception of alopecia.

  • Known active severe or poorly controlled acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: ABBV-787
Phase: 1
Study Start date:
November 13, 2023
Estimated Completion Date:
February 25, 2025

Connect with a study center

  • Monash Health - Monash Medical Centre /ID# 253841

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Medical Centre /ID# 253841

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 253841

    Melbourne, Victoria 3168
    Australia

    Site Not Available

  • Peter MacCallum Cancer Ctr /ID# 252517

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 252913

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 252914

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 252915

    Jerusalem, 91120
    Israel

    Site Not Available

  • National Cancer Center Hospital East /ID# 252519

    Kashiwa-shi, Chiba 277-8577
    Japan

    Site Not Available

  • Yamagata University Hospital /ID# 254105

    Yamagata-shi, Yamagata 990-9585
    Japan

    Site Not Available

  • Asan Medical Center /ID# 253955

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital /ID# 252916

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System Severance Hospital /ID# 253956

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • City of Hope /ID# 253727

    Duarte, California 91010
    United States

    Site Not Available

  • UC Davis Medical Center /ID# 252723

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California Davis Health /ID# 252723

    Sacramento, California 95817
    United States

    Site Not Available

  • uc davis medical center - patient support services building /ID# 252723

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Yale University School of Medicine /ID# 252724

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Northwestern Memorial Hospital /ID# 252800

    Chicago, Illinois 60611-2927
    United States

    Site Not Available

  • University of Chicago Medical /ID# 252764

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Maryland Medical Center /ID# 253726

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • University of Maryland, Baltimore /ID# 253726

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Cancer & Hematology Centers /ID# 252803

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252515

    New York, New York 10065-6007
    United States

    Site Not Available

  • Weill Cornell Medical College /ID# 252516

    New York, New York 10065
    United States

    Site Not Available

  • University of Pennsylvania /ID# 252789

    Philadelphia, Pennsylvania 19104-5502
    United States

    Site Not Available

  • St. David's South Austin Medical Center /ID# 252790

    Austin, Texas 78704
    United States

    Site Not Available

  • MD Anderson Cancer Center /ID# 252514

    Houston, Texas 77030
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center /ID# 253730

    Seattle, Washington 98109-1024
    United States

    Site Not Available

  • Wisconsin Medical Center /ID# 252513

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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