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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
BCL6 Molecular Glue
LY4584180
Phase
1
Recruiting
Recruiting Info
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
Related Resources:
NOVA-BCL6-1
Key Inclusion Criteria
  • Have been diagnosed with and previously treated for any of the following hematologic malignancies and have received at least 2 prior lines of systemic therapy (or must not be eligible for or be unwilling to receive available therapies)
  • 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
    • DLBCL transformed from indolent lymphomas
    • Follicular lymphoma (FL) 3b (follicular LBCL)
    • FL (Grade 1-3a)
    • Small lymphocytic lymphoma (SLL): Prior BTK inhibitor and BCL2 inhibitor required
    • Marginal zone lymphoma (MZL)
    • Waldenström macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL): Prior BTK inhibitor required
  • Phase 1a backfill and 1b only:
    • Mantle cell lymphoma (MCL)
    • Chronic lymphocytic leukemia (CLL)/SLL: Prior BTK inhibitor and BCL2 inhibitor required
    • Richter’s transformation
  • 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 central nervous system (CNS) involvement by systemic lymphoma
    • Except patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS disease may be eligible with sponsor approval
  • Have known active cytomegalovirus (CMV) or hepatitis C virus (HCV) infection
  • HIV and hepatitis B must be adequately controlled
  • Have significant cardiovascular disease
    • Unstable angina or myocardial infarction within 2 months
    • Documented left ventricular ejection fraction by any method of ≤40% within 12 months
    • QTcF >470 msec during screening
    • ≥Grade 3 New York Heart Association functional classification system of heart failure, or uncontrolled or symptomatic arrhythmias
  • Have active uncontrolled autoimmune cytopenia
a
This clinical trial is being conducted globally.
b
≥2 prior lines of therapy.
c
Backfill includes all dose escalation histologies as well as R/R Richter transformation, MCL, and CLL with sponsor approval.
d
Prior CAR T-cell therapy is required unless not a candidate.
e
Prior BTKi and BCL2i are required.
f
Prior BTKi is required.
g
Participants will be randomized to 2 or more selected dose levels, with adaptive randomization starting at equal allocation; more than one tumor type may be explored separately in distinct dose-optimization cohorts.
h
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.
For information on trial enrollment, locations, and more, call 1-877-285-4559.
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