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

What's the purpose of this trial?

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: third line or later of treatment (3L) + 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 CLL or non-GCB DLBCL. Approximately 128 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 in 28-day cycles, until the MAD/MTD is determined. In the dose expansion phase of the study participants receive oral ABBV-101 in 28-day cycles. 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.

This is an upcoming trial that has not yet started accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* For Dose Escalation (Part 1) only: Participants with documented diagnosis for one of the following 3L+ B-cell malignancies, from one of the following 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)
* For Dose Expansion (Part 2) only: Participants with documented diagnosis of CLL who are 3L+ including those with Bruton's tyrosine kinase (BTK) mutations or CAR-T/HCT R/R or ineligible non-GCB DLBCL who are 3L+ 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.
* 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.
* Participants with prior central nervous system (CNS) disease that have been effectively treated may be eligible.

Exclusion Criteria:

* Previously treated with a Bruton's tyrosine kinase (BTK) degrader.
* Known active CNS disease, or primary CNS lymphoma.
* Uncontrolled active systemic infection, or active cytomegalovirus infection, known history of human immunodeficiency virus (HIV), active hepatitis B or C infection.

Additional Trial Information

Phase 1

Enrollment: 128 patients (estimated)

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Trial Locations

All Trial Locations

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New York

New York Oncology Hematology - Albany Cancer Center

Albany, NY

Not Yet Accepting

Northwell Health Monter Cancer Center

Lake Success, NY

Not Yet Accepting

University of Rochester Medical Center James P. Wilmot Cancer Center

Rochester, NY

Not Yet Accepting


University of Pennsylvania (Penn Med)

Philadelphia, PA

Not Yet Accepting


MD Anderson Cancer Center The University of Texas

Houston, TX

Not Yet Accepting
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