RecruitingPhase 1NCT07226843

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

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


Sponsor

Eli Lilly and Company

Enrollment

460 participants

Start Date

Apr 17, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 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

Exclusion Criteria5

  • 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

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Interventions

DRUGLY4584180

administered orally

DRUGRituximab

administered through IV infusion


Locations(46)

Mayo Clinic - Scottsdale

Scottsdale, Arizona, United States

City of Hope

Duarte, California, United States

University of California, Los Angeles (UCLA) - Medical Center

Los Angeles, California, United States

University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

University of Miami - Sylvester Cancer Center

Miami, Florida, United States

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Columbia University

New York, New York, United States

University of Rochester

Rochester, New York, United States

The Ohio State University (OSU)

Columbus, Ohio, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Oncology - DFW (Sammons CC)

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Washington - Fred Hutchinson Cancer Center (Seattle Cancer Care Alliance)

Seattle, Washington, United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

CHU de Nantes - Hotel-Dieu

Nantes, France

Institut Curie

Paris, France

CHU Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie

Pessac, France

HCL Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Oncopole Claudius Regaud

Toulouse, France

Charite Universitaetsmedizin Berlin

Berlin, Germany

Universitaetsklinikum Koeln (AoeR)

Cologne, Germany

Universitaetsklinikum Essen

Essen, Germany

Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet

Frankfurt am Main, Germany

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola

Bologna, Italy

Istituto Europeo di Oncologia

Milan, Italy

National Cancer Center Hospital East

Chiba, Japan

Okayama University Hospital

Okayama, Japan

Cancer Institute Hospital of JFCR

Tokyo, Japan

Pratia Onkologia Katowice

Katowice, Poland

Pratia MCM Krakow

Krakow, Poland

AIDPORT Sp. z o.o.

Skorzewo, Poland

Instytut Hematologii i Transfuzjologii w Warszawie

Warsaw, Poland

Institut Catala d'Oncologia - L'Hospitalet

Barcelona, Spain

South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

Madrid, Spain

King's College Hospital

London, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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