A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers

NCT07226843
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
460
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
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Start date
2026-04-17
clinicaltrials.gov
Number of sites
46
clinicaltrials.gov

Summary
The main purpose of this study is to evaluate safety and efficacy, and measure how much LY4584180 gets into the bloodstream and how long it takes the body to eliminate it in patients with previously treated blood cancers. For each participant, the study could last about 9 months or possibly longer including screening.
clinicaltrials.gov
Short title
A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
clinicaltrials.gov
Official title
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 Malignancies
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-02-01
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First posted
2025-11-12
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Registry last updated
2026-08-06
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Primary completion date
2027-04-01
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Start date
2026-04-17
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Participants
460
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Participant count basis
Estimated
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Planned participants
460
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Protocol amendments
1
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Number of sites
46
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07226843
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ClinicalTrials.gov ID
NCT07226843
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities

    Timeframe: Baseline up to Day 28

    Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities

  2. Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Timeframe: Baseline up to 3 Years

    Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  3. To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)

    Timeframe: Baseline up to 3 Years

    To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)

  1. Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180

    Timeframe: Baseline to Day 8

    PK: Cmax of LY4584180

  2. PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180

    Timeframe: Baseline to Day 8

    PK: AUC versus time curve of LY4584180

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Has been treated for the following blood cancers and has received at least 2 prior lines of systemic therapy or not eligible for available therapy:

    • Diffuse large B-cell lymphoma - not otherwise specified
    • High-grade B-cell lymphoma
    • Diffuse large B-cell lymphoma - transformed from indolent lymphomas
    • Follicular large B-cell lymphoma
    • Follicular lymphoma
    • Other non-Hodgkin lymphoma

  • Has measurable disease

  • Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy

  • Has an active second cancer
  • Has known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS disease may be eligible and enrolled if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval.
  • Has known Cytomegalovirus infection. Participants with negative status are eligible
  • Has known hepatitis B or C infection or uncontrolled HIV
  • Has known significant heart disease
Sources for eligibility
clinicaltrials.gov

  • Mayo Clinic - ScottsdaleScottsdale, United StatesRecruiting
  • City of HopeDuarte, United StatesRecruiting
  • University of California, Los Angeles (UCLA) - Medical CenterLos Angeles, United StatesNot yet recruiting
  • University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesNot yet recruiting
  • Colorado Blood Cancer InstituteDenver, United StatesRecruiting
  • University of Miami - Sylvester Cancer CenterMiami, United StatesRecruiting
  • Florida Cancer Specialists - SarasotaSarasota, United StatesRecruiting
  • Emory University HospitalAtlanta, United StatesRecruiting
  • Massachusetts General HospitalBoston, United StatesRecruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • Mayo Clinic - RochesterRochester, United StatesRecruiting
  • Columbia UniversityNew York, United StatesRecruiting
  • University of RochesterRochester, United StatesRecruiting
  • The Ohio State University (OSU)Columbus, United StatesRecruiting
  • Oregon Health & Science University (OHSU)Portland, United StatesNot yet recruiting
  • Sarah Cannon Research InstituteNashville, United StatesRecruiting
  • Vanderbilt University Medical CenterNashville, United StatesRecruiting
  • Texas Oncology - DFW (Sammons CC)Dallas, United StatesRecruiting
  • Baylor College of MedicineHouston, United StatesNot yet recruiting
  • University of Washington - Fred Hutchinson Cancer Center (Seattle Cancer Care Alliance)Seattle, United StatesRecruiting
  • Froedtert Hospital and the Medical College of WisconsinMilwaukee, United StatesRecruiting
  • CHU de Nantes - Hotel-DieuNantes, FranceNot yet recruiting
  • Institut CurieParis, FranceNot yet recruiting
  • CHU Bordeaux - Hopital Haut-Leveque - Centre Francois MagendiePessac, FranceNot yet recruiting
  • HCL Centre Hospitalier Lyon SudPierre-Bénite, FranceNot yet recruiting

And 21 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523601-16-00
  • J6Y-OX-JBFA
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (5)

Targets (1)