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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/NCT05618028




Registration number
NCT05618028
Ethics application status
Date submitted
14/11/2022
Date registered
16/11/2022
Date last updated
19/04/2024

Titles & IDs
Public title
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
Scientific title
A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
Secondary ID [1] 0 0
M23-324
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma 0 0
Chronic Lymphocytic Leukemia 0 0
B Cell Malignancies 0 0
Non-Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-525

Experimental: ABBV-525 Dose Escalation - Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period.

Experimental: ABBV-525 Dose Optimization - Participants will receive one of two doses of ABBV-525 until the recommended phase 2 dose (RP2D) is determined, as part of an approximately 64 month study period.

Experimental: ABBV-525 Dose Expansion - Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period.


Treatment: Drugs: ABBV-525
Oral; Tablet
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 64 Months
Primary outcome [2] 0 0
Number of Participants With Dose-Limiting Toxicities (DLT)
Timepoint [2] 0 0
Up to Approximately 28 Days
Primary outcome [3] 0 0
Number of Tumor Lysis Syndrome (TLS)
Timepoint [3] 0 0
Up to Approximately 64 Months
Primary outcome [4] 0 0
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Timepoint [4] 0 0
Up to Approximately 64 Months
Primary outcome [5] 0 0
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Timepoint [5] 0 0
Up to Approximately 64 Months
Primary outcome [6] 0 0
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
Timepoint [6] 0 0
Up to Approximately 64 Months
Primary outcome [7] 0 0
Maximum Observed Plasma Concentration (Cmax) of ABBV-525
Timepoint [7] 0 0
Up to 12 Months
Primary outcome [8] 0 0
Time to Cmax (Tmax) of ABBV-525
Timepoint [8] 0 0
Up to 12 Months
Primary outcome [9] 0 0
Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-525
Timepoint [9] 0 0
Up to 12 Months
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to Approximately 64 Months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to Approximately 64 Months

Eligibility
Key inclusion criteria
- Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of the
following third line or later of treatment (3L)+ mature B-cell malignancies, from the
World Health Organization (WHO)-defined histologies as defined in the protocol.

- Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic
lymphocytic leukemia (CLL) who are 3L+, +/- cysteine-to-serine point mutation at
residue 481 of BTK-domain active site (C481S with histology based on WHO criteria,
with measurable disease requiring treatment as defined by the International Workshop
on Chronic Lymphocytic Leukemia (iwCLL).

- Dose Expansion (Part 3) Only: Participants with documented diagnosis of non-germinal
center B cell (GCB) Diffuse large B-cell lymphoma (DLBCL) who are 3L+ chimeric antigen
receptor T-cells (CAR-T)/Hematopoietic cell transplant (HCT) relapsed/refractory (R/R)
and/or ineligible with histology based on WHO criteria, with measurable disease
requiring treatment.

- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
of 0 or 1.

- Participant has a life expectancy >= 12 weeks.

- Adequate hematological and hepatic function as defined in the protocol.

- Must have archival or freshly collected tumor tissue for correlative studies before
study enrollment.

- Participants with prior central nervous system (CNS) disease that has been effectively
treated may be eligible.

- Participants with resolved coronavirus disease 2019 (COVID-19) infection are eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known active CNS disease, or primary CNS lymphoma.

- Known bleeding disorders.

- Known history of stroke or intracranial hemorrhage within 12 months prior to first
dose of study treatment.

- Uncontrolled active systemic infection, or active cytomegalovirus infection.

- Active hepatitis B or C infection.

- Known history of human immunodeficiency virus (HIV).

- Known active COVID-19 infection. Participant must not have signs/symptoms associated
with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection
during screening. If participant has signs/symptoms suggestive of COVID-19 infection,
the participant must have a negative molecular (eg, polymerase chain reaction) test or
3 negative antigen test results at least 24 hours apart.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Other
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
4/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/06/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University /ID# 246366 - Clayton
Recruitment hospital [2] 0 0
Alfred Health /ID# 248592 - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3004 - 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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
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
North Carolina
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
Belgium
State/province [10] 0 0
Oost-Vlaanderen
Country [11] 0 0
Belgium
State/province [11] 0 0
Vlaams-Brabant
Country [12] 0 0
France
State/province [12] 0 0
Nord
Country [13] 0 0
France
State/province [13] 0 0
Toulouse Cedex 9
Country [14] 0 0
Israel
State/province [14] 0 0
H_efa
Country [15] 0 0
Israel
State/province [15] 0 0
HaMerkaz
Country [16] 0 0
Israel
State/province [16] 0 0
Tel-Aviv
Country [17] 0 0
Israel
State/province [17] 0 0
Yerushalayim
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell
responsible for fighting infections. The purpose of this study is to assess safety,
tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy.

ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies.
Study doctors put the participants in groups called treatment arms. Participants will receive
ABBV-525 at different doses. Approximately 100 adult participants will be enrolled in the
study across sites worldwide.

In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In
part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525,
until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion),
participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study
is up to 64 months.

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 and may require frequent medical assessments, blood tests, and scans.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05618028
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/NCT05618028