ABBV-291
DrugIntravenous Infusion
NCT Number: NCT06667687
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
St Vincent's Hospital Melbourne /ID# 261664, Fitzroy Melbourne, Victoria, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous Infusion
Time frame: Up to 74 Months
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.
Time frame: Up to 74 Months
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.
Time frame: Up to 74 Months
Percentage of participants with clinically significant laboratory values (chemistry, and hematology).
Time frame: Up to 74 Months
Vital sign are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.
Time frame: Up to 74 Months
Percentage of participants with clinically significant ECG findings.
Time frame: Up to 74 Months
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).
Time frame: Up to 74 Months
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.
Time frame: Up to 74 Months
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.
Time frame: Up to 74 Months
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.
Time frame: Up to 12 Months
AUC is defined as the area under the plasma/serum concentration-time curve of ABBV-291.
Time frame: Up to 12 Months
Cmax is defined as maximum observed plasma/serum concentration of ABBV-291.
Time frame: Up to 12 Months
Tmax is defined as time to Cmax of ABBV-291.
Time frame: Up to 12 Months
t1/2 is defined as the half-life of ABBV-291.
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00596804
Hemic and Lymphatic Diseases, Immune System Diseases
Lille, Cedex, France
View Trial DetailsNCT02661035
Acute Lymphocytic Leukemia, Acute Myelogenous Leukemia
Minneapolis, Minnesota, United States
View Trial DetailsNCT00406809
Chronic Lymphoid Leukemia, Follicular Lymphoma
Los Angeles, California, United States
View Trial DetailsNCT00794638
Diffuse Large B-cell Lymphoma, Follicular Lymphoma
Nagoya, Aichi-ken, Japan
View Trial Details