Trial Title:
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
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
Acute Myeloid Leukemia
AML
ABBV-787
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABBV-787
Description:
Intravenous (IV) Infusion
Arm group label:
ABBV-787
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope /ID# 253727
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Davis Health /ID# 252723
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale University School of Medicine /ID# 252724
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern Memorial Hospital /ID# 252800
Address:
City:
Chicago
Zip:
60611-2927
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Medical /ID# 252764
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Maryland Medical Center /ID# 253726
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer & Hematology Centers /ID# 252803
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252515
Address:
City:
New York
Zip:
10065-6007
Country:
United States
Status:
Recruiting
Facility:
Name:
Weill Cornell Medical College /ID# 252516
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pennsylvania /ID# 252789
Address:
City:
Philadelphia
Zip:
19104-5502
Country:
United States
Status:
Recruiting
Facility:
Name:
St. David's South Austin Medical Center /ID# 252790
Address:
City:
Austin
Zip:
78704
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center /ID# 252514
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Research Center /ID# 253730
Address:
City:
Seattle
Zip:
98109-1024
Country:
United States
Status:
Recruiting
Facility:
Name:
Wisconsin Medical Center /ID# 252513
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Facility:
Name:
Monash Medical Centre /ID# 253841
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Ctr /ID# 252517
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Chaim Sheba Medical Center /ID# 252913
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel Aviv Sourasky Medical Center /ID# 252914
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center-Hebrew University /ID# 252915
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East /ID# 252519
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yamagata University Hospital /ID# 254105
Address:
City:
Yamagata-shi
Zip:
990-9585
Country:
Japan
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital /ID# 252916
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center /ID# 253955
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Yonsei University Health System Severance Hospital /ID# 253956
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Start date:
November 13, 2023
Completion date:
October 20, 2029
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06068868
https://www.abbvieclinicaltrials.com/study/?id=M23-477
