Study to Evaluate Adverse Events, Change in Disease Activity, Movement of Oral ABBV-623 and ABBV-992 Tablets in the Body of Adult Participants With B-cell Cancers

Study Identifier
M20-208
CT.gov Identifier
NCT04804254
EudraCT Identifier
2020-005196-12
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
    • Study Drug
  • ABBV-623
  • ABBV-992
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants must have documented diagnosis for one of the following B-cell malignancies: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Waldenström's macroglobulinemia (WM), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL), with measurable disease requiring treatment. * Participants have relapsed or refractory to at least 2 prior systemic therapies. * Combination Dose Expansion Only: Participants with documented diagnosis of CLL/SLL with measurable disease requiring treatment per by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. * Eastern Cooperative Oncology Group performance status of 0 or 1. * CLL/SLL, MCL, WM, MZL only: Prior Bruton's tyrosine kinase inhibitor (BTKi) exposure will be allowed if participant did not progress on active treatment and there is no evidence of resistance mutations. * Renal, liver and hematological function lab values as determined in the protocol. * For participants with prior BTK inhibitor exposure, no evidence of mutations which confer resistance to covalent BTK inhibitors.
    Exclusion Criteria:
    * Participants with indolent forms of non-Hodgkin lymphoma (NHL) that require immediate cytoreduction. * Participants with prior B-cell lymphoma 2 (BCL2) inhibitor (BCL2i) exposure (except for participants in the ABBV-992 monotherapy cohort).

    Protocol Summary

    B-cell cancer is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The main objective of this study is to evaluate the safety and efficacy of ABBV-623 and ABBV-992 given alone and in combination in treating B-cell cancers. Adverse events, change in disease activity and how the drug moves through the body of adult participants with B-cell cancers will be evaluated.

    ABBV-623 and ABBV-992 are investigational drugs being developed for the treatment of B-cell cancer. Study doctors assign participants to one of six groups, called treatment arms. Approximately 105 adult participants with a diagnosis of B-cell cancer will be enrolled in the study at approximately 50 sites worldwide.

    Participants in the combination expansion treatment arms will receive oral tablets of ABBV-623 and/or ABBV-992 once daily for 24 months. All other arms are treated until progression.

    Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be evaluated by medical assessments and blood tests. Adverse events will be collected and assessed throughout the clinical trial.

    Study Locations

    Location
    Status
    Location
    The Chaim Sheba Medical Center /ID# 226754
    Ramat Gan, Tel Aviv, Israel, 5265601
    Status
    Not applicable
    Location
    Tel Aviv Sourasky Medical Center /ID# 226755
    Tel Aviv, Tel Aviv, Israel, 6423906
    Status
    Not applicable
    Location
    Hospital del Centro Comprensivo de Cancer de la UPR /ID# 225646
    San Juan, Puerto Rico, 00927
    Status
    Not applicable
    Location
    Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 226087
    Ankara, Turkey, 06200
    Status
    Not applicable
    Location
    Dokuz Eylul University Medical Faculty /ID# 226085
    Izmir, Turkey, 35340
    Status
    Not applicable