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A Phase 1 First-In-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV 291 as Monotherapy and in Combination in Non-Hodgkin's Lymphoma
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Carolina BioOncology Institute /ID# 265259
Huntersville, North Carolina, United States
Willamette Valley Cancer Institute and Research Center /ID# 270945
Eugene, Oregon, United States
Texas Oncology - Central/South Texas /ID# 270946
Austin, Texas, United States
START Mountain Region /ID# 267592
West Valley City, Utah, United States
Virginia Cancer Specialists - Fairfax /ID# 265082
Fairfax, Virginia, United States
St Vincent's Hospital Melbourne /ID# 261664
Fitzroy Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital /ID# 268579
Nedlands, Western Australia, Australia
Hadassah Medical Center-Hebrew University /ID# 261658
Jerusalem, Jerusalem, Israel
Tel Aviv Sourasky Medical Center /ID# 261659
Tel Aviv, Tel Aviv, Israel
Aichi Cancer Center /ID# 267471
Nagoya, Aichi-ken, Japan
Start Date
January 16, 2025
Primary Completion Date
January 1, 2027
Completion Date
November 1, 2031
Last Updated
January 26, 2026
165
ESTIMATED participants
ABBV-291
DRUG
Lead Sponsor
AbbVie
NCT05623982
NCT03314974
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04586478