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)
NCT ID: NCT06068868
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
36 participants
INTERVENTIONAL
2023-11-13
2025-02-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ABBV-787
Participants will receive increasing doses of ABBV-787 until the maximum tolerated dose (MTD) during the 3 year treatment period.
ABBV-787
Intravenous (IV) Infusion
Interventions
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ABBV-787
Intravenous (IV) Infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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City of Hope /ID# 253727
Duarte, California, United States
University of California Davis Health /ID# 252723
Sacramento, California, United States
Yale University School of Medicine /ID# 252724
New Haven, Connecticut, United States
Northwestern Memorial Hospital /ID# 252800
Chicago, Illinois, United States
University of Chicago Medical /ID# 252764
Chicago, Illinois, United States
University of Maryland, Baltimore /ID# 253726
Baltimore, Maryland, United States
Cancer & Hematology Centers /ID# 252803
Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252515
New York, New York, United States
Weill Cornell Medical College /ID# 252516
New York, New York, United States
University of Pennsylvania /ID# 252789
Philadelphia, Pennsylvania, United States
St. David's South Austin Medical Center /ID# 252790
Austin, Texas, United States
MD Anderson Cancer Center /ID# 252514
Houston, Texas, United States
Fred Hutchinson Cancer Research Center /ID# 253730
Seattle, Washington, United States
Wisconsin Medical Center /ID# 252513
Milwaukee, Wisconsin, United States
Monash Health - Monash Medical Centre /ID# 253841
Clayton, Victoria, Australia
Peter MacCallum Cancer Ctr /ID# 252517
Melbourne, Victoria, Australia
The Chaim Sheba Medical Center /ID# 252913
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 252914
Tel Aviv, Tel Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 252915
Jerusalem, , Israel
National Cancer Center Hospital East /ID# 252519
Kashiwa-shi, Chiba, Japan
Yamagata University Hospital /ID# 254105
Yamagata, Yamagata, Japan
Seoul National University Hospital /ID# 252916
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 253955
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 253956
Seoul, , South Korea
Countries
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Related Links
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Other Identifiers
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2023-505233-27-00
Identifier Type: OTHER
Identifier Source: secondary_id
M23-477
Identifier Type: -
Identifier Source: org_study_id
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