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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT06068868
Ethics application status
Date submitted
29/09/2023
Date registered
5/10/2023

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
NA
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
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Israel
State/province [11] 0 0
Tel-Aviv
Country [12] 0 0
Israel
State/province [12] 0 0
Jerusalem
Country [13] 0 0
Japan
State/province [13] 0 0
Chiba
Country [14] 0 0
Japan
State/province [14] 0 0
Yamagata
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul Teugbyeolsi
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06068868