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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
Date last updated
28/05/2025
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
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Scientific title
A Phase 1 First-In-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-291 in Non-Hodgkin's Lymphoma
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Secondary ID [1]
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2024-512586-13-00
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Secondary ID [2]
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M24-893
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with Adverse Events (AE)s
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment.
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Timepoint [1]
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Up to 74 Months
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Primary outcome [2]
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Percentage of Participants with Dose Limiting Toxicities (DLT)s
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Assessment method [2]
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DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
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Timepoint [2]
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Up to 74 Months
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Primary outcome [3]
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Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, and Hematology)
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Assessment method [3]
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Percentage of participants with clinically significant laboratory values (chemistry, and hematology).
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Timepoint [3]
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Up to 74 Months
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Primary outcome [4]
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Percentage of Participants with Clinically Significant Vital Sign Measurements
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Assessment method [4]
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Vital sign are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.
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Timepoint [4]
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Up to 74 Months
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Primary outcome [5]
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Percentage of Participants with Clinically Significant Electrocardiogram (ECG) Findings
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Assessment method [5]
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Percentage of participants with clinically significant ECG findings.
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Timepoint [5]
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Up to 74 Months
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Primary outcome [6]
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Objective Response Rate (ORR)
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Assessment method [6]
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ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) or better per disease-specific response criteria (e.g., Lugano classification).
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Timepoint [6]
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Up to 74 Months
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Secondary outcome [1]
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Duration of Response (DOR) as Assessed by Investigator
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Assessment method [1]
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DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to disease-specific response criteria to disease progression or death of any cause, whichever occurs earlier.
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Timepoint [1]
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Up to 74 Months
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Secondary outcome [2]
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Progression-Free Survival (PFS) as Assessed by Investigator
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Assessment method [2]
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PFS is defined as time from first study treatment to a documented disease progression according to disease-specific response criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.
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Timepoint [2]
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Up to 74 Months
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Secondary outcome [3]
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Time to response (TTR)
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Assessment method [3]
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TTR is defined as time from first study treatment to the initial response of PR (or better) per investigator review according to disease-specific response criteria.
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Timepoint [3]
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Up to 74 Months
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Secondary outcome [4]
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Area Under the Curve (AUC) of ABBV-291
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Assessment method [4]
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AUC is defined as the area under the plasma/serum concentration-time curve of ABBV-291.
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Timepoint [4]
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Up to 12 Months
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Secondary outcome [5]
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Maximum Observed Plasma/Serum Concentration (Cmax) of ABBV-291
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Assessment method [5]
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Cmax is defined as maximum observed plasma/serum concentration of ABBV-291.
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Timepoint [5]
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Up to 12 Months
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Secondary outcome [6]
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Time to Cmax (Tmax) of ABBV-291
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Assessment method [6]
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Tmax is defined as time to Cmax of ABBV-291.
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Timepoint [6]
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Up to 12 Months
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Secondary outcome [7]
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Half-Life (t1/2) of ABBV-291
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Assessment method [7]
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t1/2 is defined as the half-life of ABBV-291.
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Timepoint [7]
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Up to 12 Months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/01/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2031
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Actual
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Sample size
Target
165
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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St Vincent's Hospital Melbourne /ID# 261664 - Fitzroy Melbourne
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Recruitment postcode(s) [1]
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3065 - Fitzroy Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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North Carolina
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Country [2]
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United States of America
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State/province [2]
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Oregon
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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United States of America
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State/province [4]
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Utah
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Country [5]
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United States of America
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State/province [5]
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Virginia
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Country [6]
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Israel
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State/province [6]
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Tel-Aviv
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Country [7]
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Israel
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State/province [7]
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Yerushalayim
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Country [8]
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Japan
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State/province [8]
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Aichi
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Country [9]
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Japan
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State/province [9]
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Tokyo
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or refractory (R/R) NHL, including but not limited to diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Adverse events will be assessed. ABBV-291 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-291 and a dose expansion/optimization phase to determine the change in disease activity in participants with R/R NHL. Approximately 165 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide In the dose escalation phase of the study participants will receive escalating Intravenously (IV) infused doses of ABBV-291, until the MAD/MTD is determined. In the dose expansion/optimization phase of the study participants receive IV infused ABBV-291, as part of the approximately 74 month study duration. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
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Trial website
https://clinicaltrials.gov/study/NCT06667687
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
Download to PDF