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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06068868




Registration number
NCT06068868
Ethics application status
Date submitted
29/09/2023
Date registered
5/10/2023
Date last updated
29/05/2024

Titles & IDs
Public 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)
Scientific title
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-787 in Adult Subjects With Acute Myeloid Leukemia (AML)
Secondary ID [1] 0 0
2023-505233-27-00
Secondary ID [2] 0 0
M23-477
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-787

Experimental: ABBV-787 - Participants will receive increasing doses of ABBV-787 until the maximum tolerated dose (MTD) during the 3 year treatment period.


Treatment: Drugs: ABBV-787
Intravenous (IV) Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AE)
Timepoint [1] 0 0
Up to Approximately 3 Years
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD) Based on Dose-Limiting Toxicities (DLT)
Timepoint [2] 0 0
Up to approximately 28 Days
Secondary outcome [1] 0 0
Area Under the Plasma Concentration-time Curve (AUC) of ABBV-787
Timepoint [1] 0 0
Up to Approximately 1 Year
Secondary outcome [2] 0 0
Maximum Observed Concentration (Cmax) of ABBV-787
Timepoint [2] 0 0
Up to Approximately 1 Year
Secondary outcome [3] 0 0
Time to Cmax (Tmax) of ABBV-787
Timepoint [3] 0 0
Up to Approximately 1 Year
Secondary outcome [4] 0 0
Half-life (t1/2) of ABBV-787
Timepoint [4] 0 0
Up to Approximately 1 Year
Secondary outcome [5] 0 0
Total Antibody Concentration
Timepoint [5] 0 0
Up to Approximately 1 Year
Secondary outcome [6] 0 0
Plasma Concentrations of Unconjugated Bromodomain and Extra-terminal Domain (BET) Degrader Payload
Timepoint [6] 0 0
Up to Approximately 1 Year
Secondary outcome [7] 0 0
Antidrug Antibody (ADA)
Timepoint [7] 0 0
Up to Approximately 1 Year
Secondary outcome [8] 0 0
Neutralizing Antibody (nAb)
Timepoint [8] 0 0
Up to Approximately 1 Year
Secondary outcome [9] 0 0
Percentage of Participants Achieving Complete Remission (CR)
Timepoint [9] 0 0
Up to Approximately 1 Year
Secondary outcome [10] 0 0
Rate of Participants Achieving CR with partial hematologic recovery (CRh)
Timepoint [10] 0 0
Up to Approximately 1 Year
Secondary outcome [11] 0 0
Rate of Participants Achieving CR with incomplete hematologic recovery (CRi)
Timepoint [11] 0 0
Up to Approximately 1 Year
Secondary outcome [12] 0 0
Rate of Participants Achieving Composite CR (CR, CRh, or CRi)
Timepoint [12] 0 0
Up to Approximately 1 Year
Secondary outcome [13] 0 0
Rate of Participants Achieving Partial Remission (PR)
Timepoint [13] 0 0
Up to Approximately 1 Year
Secondary outcome [14] 0 0
Duration of Response (DOR)
Timepoint [14] 0 0
Up to Approximately 1 Year
Secondary outcome [15] 0 0
Number of Participants proceeding to hematopoietic stem cell transplant (HSCT)
Timepoint [15] 0 0
Up to Approximately 3 Years
Secondary outcome [16] 0 0
Event-free Survival (EFS)
Timepoint [16] 0 0
Up to Approximately 3 Years
Secondary outcome [17] 0 0
Relapse free survival (RFS)
Timepoint [17] 0 0
Up to Approximately 3 Years
Secondary outcome [18] 0 0
Overall survival (OS)
Timepoint [18] 0 0
Up to Approximately 3 Years

Eligibility
Key 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.).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/10/2029
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre /ID# 253841 - Clayton
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Ctr /ID# 252517 - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Israel
State/province [8] 0 0
Tel-Aviv
Country [9] 0 0
Israel
State/province [9] 0 0
Yerushalayim
Country [10] 0 0
Japan
State/province [10] 0 0
Chiba
Country [11] 0 0
Japan
State/province [11] 0 0
Yamagata
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul Teugbyeolsi
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06068868
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06068868