Status:
TERMINATED
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)
Lead Sponsor:
AbbVie
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 move...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06068868
Start Date
November 13 2023
End Date
February 25 2025
Last Update
March 6 2025
Active Locations (24)
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1
City of Hope /ID# 253727
Duarte, California, United States, 91010
2
University of California Davis Health /ID# 252723
Sacramento, California, United States, 95817
3
Yale University School of Medicine /ID# 252724
New Haven, Connecticut, United States, 06510
4
Northwestern Memorial Hospital /ID# 252800
Chicago, Illinois, United States, 60611-2927