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A Phase 1 First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of ABBV-623 and ABBV-992 in Subjects With B-cell Malignancies
B-cell cancer is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The main objective of this study is to evaluate the safety and efficacy of ABBV-623 and ABBV-992 given alone and in combination in treating B-cell cancers. Adverse events, change in disease activity and how the drug moves through the body of adult participants with B-cell cancers will be evaluated. ABBV-623 and ABBV-992 are investigational drugs being developed for the treatment of B-cell cancer. Study doctors assign participants to one of six groups, called treatment arms. Approximately 105 adult participants with a diagnosis of B-cell cancer will be enrolled in the study at approximately 50 sites worldwide. Participants in the combination expansion treatment arms will receive oral tablets of ABBV-623 and/or ABBV-992 once daily for 24 months. All other arms are treated until progression. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be evaluated by medical assessments and blood tests. Adverse events will be collected and assessed throughout the clinical trial.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The Chaim Sheba Medical Center /ID# 226754
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 226755
Tel Aviv, Tel Aviv, Israel
Hospital del Centro Comprensivo de Cancer de la UPR /ID# 225646
San Juan, Puerto Rico
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 226087
Ankara, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty /ID# 226085
Izmir, Turkey (Türkiye)
Start Date
April 27, 2021
Primary Completion Date
January 11, 2023
Completion Date
January 11, 2023
Last Updated
February 3, 2023
5
ACTUAL participants
ABBV-623
DRUG
ABBV-992
DRUG
Lead Sponsor
AbbVie
NCT05139017
NCT06026319
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.
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