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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
BCL6 Molecular Glue
LY4584180
Phase
1
Active, not recruiting
NOVA-BCL6-1: A First-in-Human, Multicenter Phase 1a/1b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of LY4584180 in Adult Participants With Previously Treated Hematologic Malignanciesa
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Trial Enrollment
NOVA-BCL6-1
Key Inclusion Criteria
  • Have been diagnosed with and previously treated for any of the following hematologic malignancies and has received at least 2 prior lines of systemic therapy
  • All Phases
    • Diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS)
    • High-grade B-cell lymphomas (BCLs): high-grade BCL with MYC and BCL2 and/or BCL6 rearrangement; high-grade BCL, NOS; and aggressive BCLs with 11q aberration
    • Follicular lymphoma (FL) 3b (follicular LBCL)
    • FL (Grade 1-3a)  
  • Phase 1b or 1a backfill only:
    • Mantle cell lymphoma (MCL)
    • DLBCL transformed from indolent lymphomas (including Richter’s transformation)
    • Marginal zone lymphoma (MZL)
    • Waldenström macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL): Prior therapy must have included a Bruton's tyrosine kinase (BTK) inhibitor
    • Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Prior therapy must have included a BTK inhibitor and a BCL2 inhibitor
  • Have measurable disease. Measurable disease cannot be previously irradiated
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy
  • Have adequate organ function
  • Is capable of giving signed informed consent
  • Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation
  • Had prior treatment-related adverse events (AEs) that recovered to ≤Grade 1 or pretreatment baseline with the exception of alopecia
Key Exclusion Criteria
  • Have an active second malignancy
  • Have known or suspected history of central nervous system (CNS) involvement
  • Have known active cytomegalovirus (CMV) infection
  • Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or human immunodeficiency virus (HIV) documented during screening
  • Active HBV defined as positive for hepatitis B surface antigen (HBsAg) or polymerase chain reaction (PCR)-positive for HBV DNA
  • Active HCV
  • Have significant cardiovascular disease
    • Prolongation of the QTcF >470 msec during screening
  • Have evidence of other clinically significant uncontrolled condition(s)
  • Have active uncontrolled autoimmune cytopenia
a
This clinical trial is being conducted globally.
b
Participants will be randomized to 2 or more selected dose levels. More than 1 tumor type might be explored separately in distinct dose optimization cohorts.
c
Enrollment into individual Phase 1b cohorts will only occur after evaluating sufficient nonclinical CYP data when available. Initiation of each cohort will be based on the totality of safety, efficacy, and relevant nonclinical data, and in consultation with the SRC.
d
Subject to the results of monotherapy dosing safety and preliminary efficacy. Combination therapies will be administered in regions or countries where approved and available.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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