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NCT05753501

PHASE1

Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

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, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin's lymphomas: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed. ABBV-101 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-101 and a dose expansion phase to determine the change in disease activity in participants with first line treatment (1L), second line or later of treatment (2L)+ CLL/SLL or third line or later of treatment (3L) non-GCB DLBCL. Approximately 340 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 oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 88 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101, as part of the approximately 88 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.

Official title: First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants With B-cell Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2023-06-09

Completion Date

2031-03

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Hematologic Cancer

Interventions

DRUG

ABBV-101

Oral:Tablet

Inclusion Criteria: * For Dose Escalation (Part 1) only: Participants have received at least two prior systemic therapies, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), have measurable disease requiring treatment, and have a documented diagnosis for one of the following third line or later B-cell malignancies, from one of the following world health organization (WHO)-defined histologies (Swerdlow et al 2016): * Chronic lymphocytic leukemia (CLL) * Small lymphocytic lymphoma (SLL) * Chimeric antigen receptor T-cells (CAR-T)/hematopoietic cell transplant (HCT) relapsed/refractory (R/R) or ineligible diffuse large b-cell lymphoma (DLBCL) from the following histologies: DLBCL not otherwise specified (NOS) (germinal center B cell \[GCB\] and non-GCB DLBCL), T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, anaplastic lymphoma kinase positive (ALK+) large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS. * Mantle cell lymphoma (MCL) * Follicular lymphoma \[FL\] (grades 1-3b) * Marginal zone lymphoma \[MZL\] (splenic, extranodal, and nodal) * Waldenström macroglobulinemia (WM) * Transformed indolent non-Hodgkin's lymphoma (iNHL) 1. For Dose Escalation (Part 1) - BTKi/BTKd-naïve CLL/SLL backfill only: Participants with a documented diagnosis of CLL/SLL who have received at least one prior systemic therapy that cannot be a BTK inhibitor or degrader, and, with the exception of BTK pathway agents, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment. 2. For Dose Escalation (Part 1) - BTKi/BTKd-naïve CLL/SLL backfill only: Participants with a documented diagnosis of CLL/SLL who have received one prior systemic therapy with a BTKi and BCL-2i combination regimen, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment. * For Dose Expansion (Part 2) CLL/SLL only: Participants with a documented diagnosis of CLL/SLL who have received at least one prior systemic therapy. * For Dose Expansion (Part 2) DLBCL only: Participants have received at least two prior systemic therapies, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), have measurable disease requiring treatment, and have a documented diagnosis of CAR-T/HCT R/R or ineligible non-GCB DLBCL in their third line or later treatment with histology based on criteria established by the World Health Organization (WHO). * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2. For EU only: Participant has an ECOG PS of 0 or 1. * Participant has a life expectancy \>= 12 weeks. * Prior Bruton's tyrosine kinase inhibitor (BTKi) is allowed. * Adequate hematologic, renal, and hepatic function per the protocol. Exclusion Criteria: * Previously treated with a Bruton's tyrosine kinase (BTK) degrader. * Known active central nervous system (CNS) disease, or primary CNS lymphoma. Participants with prior CNS disease that have been effectively treated may be eligible. * Uncontrolled active systemic infection requiring systemic treatment that is ongoing or was completed \<= 14 days before the first dose of study drug, or active cytomegalovirus infection.

Locations (51)

Arizona Oncology Associates, PC-HOPE /ID# 252351

Tempe, Arizona, United States

UC Irvine Medical Center /ID# 263020

Orange, California, United States

Stanford University /ID# 249683

Palo Alto, California, United States

Rocky Mountain Cancer Centers - Lone Tree /ID# 252237

Lone Tree, Colorado, United States

Northwestern University Feinberg School of Medicine /ID# 249347

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center /ID# 249302

Boston, Massachusetts, United States

Rutgers Cancer Institute of New Jersey /ID# 249323

New Brunswick, New Jersey, United States

New York Oncology Hematology - Albany Cancer Center /ID# 252240

Albany, New York, United States

Northwell Health - Monter Cancer Center /ID# 250422

Lake Success, New York, United States

University of Rochester Medical Center /ID# 249324

Rochester, New York, United States

UC Health - Cincinnati /ID# 249299

Cincinnati, Ohio, United States

Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309

Eugene, Oregon, United States

University of Pennsylvania /ID# 250341

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center /ID# 249293

Houston, Texas, United States

University Health Network_Princess Margaret Cancer Centre /ID# 253483

Toronto, Ontario, Canada

CHUM Notre-Dame Hospital /ID# 253428

Montreal, Quebec, Canada

Institut Bergonie /ID# 253664

Bordeaux, Gironde, France

CHU Montpellier - Hopital Saint Eloi /ID# 253666

Montpellier, Herault, France

CHRU Lille - Hopital Claude Huriez /ID# 253665

Lille, Nord, France

Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248

Nantes, Pays de la Loire Region, France

Institut Gustave Roussy /ID# 253662

Villejuif, Val-de-Marne, France

Hopital Saint-Louis /ID# 253663

Paris, France

Universitaetsklinikum Ulm /ID# 253742

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Wuerzburg /ID# 254636

Würzburg, Bavaria, Germany

Universitaetsmedizin Rostock /ID# 259657

Rostock, Mecklenburg-Vorpommern, Germany

Universitaetsklinikum des Saarlandes /ID# 257435

Homburg, Saarland, Germany

Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 257431

Berlin, Germany

Universitaetsklinikum Hamburg-Eppendorf /ID# 264566

Hamburg, Germany

Yitzhak Shamir Medical Center /ID# 254566

Ẕerifin, Central District, Israel

Hadassah Medical Center-Hebrew University /ID# 251123

Jerusalem, Jerusalem, Israel

The Chaim Sheba Medical Center /ID# 251122

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 259608

Tel Aviv, Tel Aviv, Israel

IRCCS Ospedale San Raffaele /ID# 253531

Milan, Milano, Italy

ASST Grande Ospedale Metropolitano Niguarda /ID# 253532

Milan, Milano, Italy

A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 253530

Turin, Piedmont, Italy

ASST Papa Giovanni XXIII /ID# 260317

Bergamo, Italy

IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255172

Bologna, Italy

National Cancer Center Hospital East /ID# 250684

Kashiwa-shi, Chiba, Japan

Kyoto University Hospital /ID# 261837

Kyoto, Kyoto, Japan

National Cancer Center Hospital /ID# 250680

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR /ID# 260375

Koto-ku, Tokyo, Japan

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260196

Majadahonda, Madrid, Spain

Hospital Universitario Vall de Hebron /ID# 260447

Barcelona, Spain

Hospital Universitario Ramon y Cajal /ID# 260450

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz /ID# 253654

Madrid, Spain

Hospital Universitario HM Sanchinarro /ID# 253655

Madrid, Spain

Hospital Universitario de Salamanca /ID# 253656

Salamanca, Spain

Addenbrookes Hospital /ID# 256242

Cambridge, Cambridgeshire, United Kingdom

Leicester Royal Infirmary /ID# 255171

Leicester, England, United Kingdom

University College London Hospital /ID# 260202

London, Greater London, United Kingdom

Kings College Hospital NHS Foundation Trust /ID# 253670

London, Greater London, United Kingdom

Clinical Research Directory

Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (51)