A Phase I First-in-human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-787 in Adult Subjects With Acute Myeloid Leukemia (AML)

Study Identifier:
M23-477
CT.gov Identifier:
NCT06068868
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2023-505233-27-00
Study Contact Information:
N/A
Terminated/Withdrawn

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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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Leukemia
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: ABBV-787
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    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's correction,
    • and no other clinically significant cardiac abnormalities.
    • - Documented diagnosis of non-promyelocytic acute myeloid leukemia (AML), per 2022
    • European Leukemia Net (ELN) criteria.
    • - Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) who have been
    • treated with up to 3 prior lines of therapy and are refractory to or intolerant of all
    • established AML therapies that are known to clearly provide clinical benefit at the
    • judgement of the investigator.
    • - Must have a white blood cell (WBC) count < 25 × 10^9 /L prior to initiation of study
    • drug (Note: Hydroxyurea or leukapheresis is permitted to meet this criterion and for
    • use through Cycle 3 to control for hyperleukocytosis.).
    Exclusion criteria
    • - Have received a CD33-targeting therapy within 3 months prior to the first dose of
    • ABBV-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 5 half-lives
    • of the drug (whichever is shorter) prior to the first dose of ABBV-787.
    • - History of documented pneumonitis that required treatment with systemic steroids
    • within the last 6 months, nor any evidence of active pneumonitis.
    • - Unresolved toxicity of Grade >= 2 from prior anticancer therapy, or to levels dictated
    • in the eligibility criteria, with the exception of alopecia.
    • - Known active severe or poorly controlled acute respiratory syndrome coronavirus 2
    • (SARS-CoV-2) infection.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Andrew Sochacki
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Leukemia