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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06667687




Registration number
NCT06667687
Ethics application status
Date submitted
30/10/2024
Date registered
31/10/2024

Titles & IDs
Public title
Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma
Scientific title
A Phase 1 First-In-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-291 in Non-Hodgkin's Lymphoma
Secondary ID [1] 0 0
2024-512586-13-00
Secondary ID [2] 0 0
M24-893
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-291

Experimental: Escalation: Non-Hodgkin Lymphoma (NHL) ABBV-291 - Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), except chronic lymphocytic leukemia (CLL), will receive escalating doses of ABBV-291, as part of the 74 month study duration.

Experimental: Expansion: Diffuse Large B-Cell Lymphoma (DLBCL) ABBV-291 - Participants with R/R DLBCL will receive the recommended Phase 1 expansion dose (RP1ED) of ABBV-291, as part of the 74 month study duration.

Experimental: Expansion: Follicular Lymphoma (FL) ABBV-291 - Participants with R/R FL will receive the RP1ED of ABBV-291, as part of the 74 month study duration.

Experimental: Optimization: Mantle Cell Lymphoma (MCL) ABBV-291 Dose A - Participants with R/R MCL will receive the dose A of ABBV-291, as part of the 74 month study duration.

Experimental: Optimization: MCL ABBV-291 Dose B - Participants with R/R MCL will receive the dose B of ABBV-291, as part of the 74 month study duration.

Experimental: Optimization: MCL ABBV-291 Dose C - Participants with R/R MCL will receive the dose C of ABBV-291, as part of the 74 month study duration.


Treatment: Drugs: ABBV-291
Intravenous Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events (AE)s
Timepoint [1] 0 0
Up to 74 Months
Primary outcome [2] 0 0
Percentage of Participants with Dose Limiting Toxicities (DLT)s
Timepoint [2] 0 0
Up to 74 Months
Primary outcome [3] 0 0
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, and Hematology)
Timepoint [3] 0 0
Up to 74 Months
Primary outcome [4] 0 0
Percentage of Participants with Clinically Significant Vital Sign Measurements
Timepoint [4] 0 0
Up to 74 Months
Primary outcome [5] 0 0
Percentage of Participants with Clinically Significant Electrocardiogram (ECG) Findings
Timepoint [5] 0 0
Up to 74 Months
Primary outcome [6] 0 0
Objective Response Rate (ORR)
Timepoint [6] 0 0
Up to 74 Months
Secondary outcome [1] 0 0
Duration of Response (DOR) as Assessed by Investigator
Timepoint [1] 0 0
Up to 74 Months
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) as Assessed by Investigator
Timepoint [2] 0 0
Up to 74 Months
Secondary outcome [3] 0 0
Time to response (TTR)
Timepoint [3] 0 0
Up to 74 Months
Secondary outcome [4] 0 0
Area Under the Curve (AUC) of ABBV-291
Timepoint [4] 0 0
Up to 12 Months
Secondary outcome [5] 0 0
Maximum Observed Plasma/Serum Concentration (Cmax) of ABBV-291
Timepoint [5] 0 0
Up to 12 Months
Secondary outcome [6] 0 0
Time to Cmax (Tmax) of ABBV-291
Timepoint [6] 0 0
Up to 12 Months
Secondary outcome [7] 0 0
Half-Life (t1/2) of ABBV-291
Timepoint [7] 0 0
Up to 12 Months

Eligibility
Key inclusion criteria
* For dose escalation (Part 1) only: Participants must have documented diagnosis of B-cell malignancies including (but not limited to) the following, with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment:

* Mantle cell lymphoma (MCL);
* Marginal zone lymphoma (MZL);
* Waldenstrom macroglobulinemia (WM);
* Diffuse large b-cell lymphoma (DLBCL) (including: germinal center B-cell type, activated B-cell type, primary cutaneous DLBCL [leg type], Epstein-Barr virus-positive (EBV+) DLBCL [not otherwise specified], DLBCL associated with chronic inflammation, human herpesvirus 8-positive [HHV8+] DLBCL [not otherwise specified], B cell lymphoma [unclassifiable] with features intermediate between DLBCL and classical Hodgkin lymphoma, high-grade B-cell lymphoma [not otherwise specified], high-grade B-cell lymphoma [with MYC (avian myelocytomatosis viral oncogene homolog) and BCL2 and/or BCL6 rearrangements], DLBCL arising from follicular lymphoma [FL] [transformed FL]);
* FL Grades 1 to 3B;
* For dose expansion (Part 2) only: Participants must have documented diagnosis of one of the following B-cell malignancies, with histology based on criteria established by the WHO, and measurable disease requiring treatment:

* Part 2a only: DLBCL (including: germinal center B-cell type, activated B-cell type, primary cutaneous DLBCL [leg type], EBV+ DLBCL [not otherwise specified], DLBCL associated with chronic inflammation, HHV8+ DLBCL [not otherwise specified], B-cell lymphoma [unclassifiable] with features intermediate between DLBCL and classical Hodgkin lymphoma, high-grade B-cell lymphoma [not otherwise specified], high-grade B-cell lymphoma [with MYC and BCL2 and/or BCL6 rearrangements], DLBCL arising from FL [transformed FL]);
* Part 2b only: FL Grades 1 to 3B;
* Part 2c only: Mantle cell lymphoma;
* For all participants (Parts 1 and 2):

* Must be considered relapsed or refractory to, or intolerant of, at least 2 or more prior lines of therapy known to provide a clinical benefit for their condition, and for whom there is no appropriate locally available therapy known to provide clinical benefit (e.g., standard chemotherapy or autologous stem cell transplantation [ASCT]).
* Indolent non-Hodkin's lymphoma (NHL) participants must meet relevant disease specific requirements for treatment (e.g., National Comprehensive Cancer Network [NCCN], Groupe d'Etude des Lymphomes Folliculaires [GELF]).
* History of allogeneic stem cell transplantation must be stable off of immunosuppression for at least 3 months.
* For participants enrolled in backfill cohorts or at dose levels previously cleared, subjects must provide consent to an on-treatment fresh tumor biopsy from the same tumor lesion as the baseline tumor tissue. This requirement may be waived at the discretion of the contract research organization (CRO) Medical Monitor if collecting a biopsy would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator or could hinder a subject's ability to participate in the study.
* Previously treated with a CD79b-targeting therapy (e.g., CD79b monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD79b-targeting therapy must be collected. Tumor biopsy requirements may be modified by Sponsor during the study. This requirement may be waived at the discretion of the contract research organization (CRO) Medical Monitor if collecting a biopsy would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator or could hinder a subject's ability to participate in the study.

* CD79b expression status will be assessed in all participants.
* Have an eastern cooperative oncology group (ECOG) Performance Status of 0 or 1.
* Laboratory values meeting the criteria in the protocol within the screening period prior to the first dose of study drug (if multiple samples are drawn within the screening period, the sample/result immediately prior to Cycle 1 Day 1 is applicable).
* Availability of representative baseline tumor tissue (most recent archived tumor tissue or fresh biopsy collected during screening phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived at the discretion of the CRO Medical Monitor if collecting a biopsy at screening would place the participant at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator or could hinder a participant's ability to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis.
* Treatment with any of the following:

* Anticancer therapy including chemotherapy, radiotherapy, small molecule, investigational, and biologic agents within 14 days (or at least 5 half-lives, whichever is shorter), prior to the first dose of the study treatment;
* CD79b-directed agents (e.g., CD79b monoclonal antibody therapy) within 4 weeks (or at least 5 half-lives, whichever is shorter) prior to the first dose of study treatment.
* Prior treatment with an antibody drug conjugate that consists of a topoisomerase I inhibitor.

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
16/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2031
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne /ID# 261664 - Fitzroy Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
United States of America
State/province [2] 0 0
Oregon
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Israel
State/province [6] 0 0
Tel-Aviv
Country [7] 0 0
Israel
State/province [7] 0 0
Yerushalayim
Country [8] 0 0
Japan
State/province [8] 0 0
Tokyo

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


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/NCT06667687