Spots Global Cancer Trial Database for Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
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Trial Identification
Brief Title: Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
Official Title: A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
Study ID: NCT05618028
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Los Angeles /ID# 246357, Los Angeles, California, United States
Mount Sinai Medical Center-Miami Beach /ID# 248251, Miami Beach, Florida, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113, Fort Wayne, Indiana, United States
Tulane Cancer Center Clinic /ID# 249586, New Orleans, Louisiana, United States
START Midwest /ID# 252359, Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459, New York, New York, United States
Levine Cancer Institute /ID# 246363, Charlotte, North Carolina, United States
University of Texas MD Anderson Cancer Center /ID# 245463, Houston, Texas, United States
Northwest Medical Specialties - Tacoma /ID# 260376, Tacoma, Washington, United States
Monash University /ID# 246366, Clayton, Victoria, Australia
Alfred Health /ID# 248592, Melbourne, Victoria, Australia
UZ Gent /ID# 246462, Gent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 246461, Leuven, Vlaams-Brabant, Belgium
CHRU Lille - Hopital Claude Huriez /ID# 252054, Lille, Nord, France
IUCT Oncopole /ID# 259409, Toulouse Cedex 9, , France
Rabin Medical Center /ID# 257665, Haifa, H_efa, Israel
Shamir Medical Center (Assaf Harofeh) /ID# 257711, Be'er Yaakov, HaMerkaz, Israel
The Chaim Sheba Medical Center /ID# 251442, Ramat Gan, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 251441, Jerusalem, Yerushalayim, Israel
Hospital Clinic de Barcelona /ID# 246543, Barcelona, , Spain
Hospital Universitario Ramon y Cajal /ID# 246540, Madrid, , Spain
The Christie Hospital /ID# 250325, Manchester, , United Kingdom
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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