Clinical Trial Finder
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
Study Purpose
B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 100 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months. 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 a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
Exclusion Criteria:
- - Known active COVID-19 infection.
Participant must not have signs/symptoms associated with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection during screening. If participant has signs/symptoms suggestive of COVID-19 infection, the participant must have a negative molecular (eg, polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: ABBV-525 Dose Escalation
Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period.
Experimental: ABBV-525 Dose Optimization
Participants will receive one of two doses of ABBV-525 until the recommended phase 2 dose (RP2D) is determined, as part of an approximately 64 month study period.
Experimental: ABBV-525 Dose Expansion
Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period.
Interventions
Drug: - ABBV-525
Oral; Tablet
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of California Los Angeles /ID# 246357
Los Angeles, California, 90095
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Mount Sinai Medical Center-Miami Beach /ID# 248251
Miami Beach, Florida, 33140-2948
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
Fort Wayne, Indiana, 46804
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Tulane Cancer Center Clinic /ID# 249586
New Orleans, Louisiana, 70112
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
START Midwest /ID# 252359
Grand Rapids, Michigan, 49546
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459
New York, New York, 10065-6007
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Levine Cancer Institute /ID# 246363
Charlotte, North Carolina, 28204
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
University of Texas MD Anderson Cancer Center /ID# 245463
Houston, Texas, 77030
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Northwest Medical Specialties - Tacoma /ID# 260376
Tacoma, Washington, 98405
Site Contact
[email protected]
844-663-3742
International Sites
Status
Recruiting
Address
Monash University /ID# 246366
Clayton, Victoria, 3168
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Alfred Health /ID# 248592
Melbourne, Victoria, 3004
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
UZ Gent /ID# 246462
Gent, Oost-Vlaanderen, 9000
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Universitair Ziekenhuis Leuven /ID# 246461
Leuven, Vlaams-Brabant, 3000
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
CHRU Lille - Hopital Claude Huriez /ID# 252054
Lille, Nord, 59037
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
IUCT Oncopole /ID# 259409
Toulouse Cedex 9, , 31059
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Rabin Medical Center /ID# 257665
Haifa, H_efa, 4941492
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Shamir Medical Center (Assaf Harofeh) /ID# 257711
Be'er Yaakov, HaMerkaz, 70300
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
The Chaim Sheba Medical Center /ID# 251442
Ramat Gan, Tel-Aviv, 5265601
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Hadassah Medical Center-Hebrew University /ID# 251441
Jerusalem, Yerushalayim, 91120
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Hospital Clinic de Barcelona /ID# 246543
Barcelona, , 08036
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
Hospital Universitario Ramon y Cajal /ID# 246540
Madrid, , 28034
Site Contact
[email protected]
844-663-3742
Status
Recruiting
Address
The Christie Hospital /ID# 250325
Manchester, , M20 4BX
Site Contact
[email protected]
844-663-3742
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