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)

Stopped early · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT06068868

Run by

AbbVie

People needed

36

Starts

2023-11-13

Expected to finish

2025-02-25

Last updated by the study team

2025-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.).

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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