First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies
- Conditions
- Hematologic Cancer
- Registration Number
- JPRN-jRCT2031230249
- Lead Sponsor
- Satomi Natsuko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 128
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, extranotal, and nodal)
--Waldenstorm 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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of Participants with Adverse Events (AE) , Change in Laboratory Parameters, Change in Vital Signs, Change in Electrocardiogram (ECG)
- Secondary Outcome Measures
Name Time Method