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

Study Identifier
M23-647
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-503594-38-00
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Recruitment Complete
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Study Details

Medical Condition
  • Blood Cancer - Other
  • Study Drug
  • ABBV-101
  • Venetoclax
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol 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. Dose expansion part 2A will follow to further determine the safety and change in disease activity in participants with first line treatment (1L\[non-US only\]), second line or later of treatment (2L)+ CLL/SLL or third line or later of treatment (3L+) non-GCB DLBCL receiving ABBV-101 alone. Dose expansion Part 2B (non-US only) will follow to determine the safety and change in disease activity in participants with 1L or 2L+ CLL/SLL receiving ABBV-101 in combination with oral venetoclax. Approximately 390 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 100 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101 alone or oral ABBV-101 at a dose determined in the dose escalation phase in combination with oral venetoclax, as part of the approximately 100 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.

    Study Locations

    Location
    Status
    Location
    Arizona Oncology Associates, PC-HOPE /ID# 252351
    Tempe, Arizona, United States, 85284-1812
    Status
    Not applicable
    Location
    UC Irvine Medical Center /ID# 263020
    Orange, California, United States, 92868-3201
    Status
    Not applicable
    Location
    Stanford University - Palo Alto /ID# 249683
    Palo Alto, California, United States, 94304
    Status
    Not applicable
    Location
    Rocky Mountain Cancer Centers - Lone Tree /ID# 252237
    Lone Tree, Colorado, United States, 80124
    Status
    Not applicable
    Location
    Northwestern University Feinberg School of Medicine /ID# 249347
    Chicago, Illinois, United States, 60611-2927
    Status
    Not applicable
    Location
    Beth Israel Deaconess Medical Center /ID# 249302
    Boston, Massachusetts, United States, 02215-5400
    Status
    Not applicable
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