Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 1 First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of ABBV-623 and ABBV-992 in Subjects With B-cell Malignancies

Keywords

B-cell Lymphoma ABBV-623 ABBV-992 Cancer 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 Follicular Lymphoma Lymphoma Lymphoma, B-Cell Monotherapy in Dose Escalation: ABBV-623 Monotherapy in Dose Escalation: ABBV-992 Monotherapy in Dose Expansion: ABBV-623 Monotherapy in Dose Expansion: ABBV-992

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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).

Locations

  • Moore UC San Diego Cancer Center /ID# 229467 not yet accepting patients
    La Jolla California 92093 United States
  • Stanford University School of Med /ID# 228092 not yet accepting patients
    Stanford California 94305-2200 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT04804254
Phase
Phase 1
Study Type
Interventional
Last Updated