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

June 3, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

460

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • France
      • Nantes, France, 44093
        • Not yet recruiting
        • CHU de Nantes - Hotel-Dieu
      • Paris, France, 75005
        • Not yet recruiting
        • Institut Curie
      • Pessac, France, 33604
        • Not yet recruiting
        • CHU Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie
      • Pierre-Bénite, France, 69495
        • Not yet recruiting
        • HCL Centre Hospitalier Lyon Sud
      • Toulouse, France, 31059
        • Not yet recruiting
        • Oncopole Claudius Regaud
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charite Universitaetsmedizin Berlin
      • Cologne, Germany, 50937
        • Not yet recruiting
        • Universitaetsklinikum Koeln (AoeR)
      • Essen, Germany, 45147
        • Not yet recruiting
        • Universitaetsklinikum Essen
      • Frankfurt am Main, Germany, 60590
        • Not yet recruiting
        • Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
      • Milan, Italy, 20141
        • Not yet recruiting
        • Istituto Europeo di Oncologia
  • Japan
      • Chiba, Japan, 277-8577
        • Not yet recruiting
        • National Cancer Center Hospital East
      • Okayama, Japan, 700-8558,
        • Not yet recruiting
        • Okayama University Hospital
      • Tokyo, Japan, 135-8550
        • Not yet recruiting
        • Cancer Institute Hospital of Jfcr
  • Poland
      • Katowice, Poland, 40-519
        • Not yet recruiting
        • Pratia Onkologia Katowice
      • Krakow, Poland, 30-727
        • Not yet recruiting
        • Pratia MCM Krakow
      • Skorzewo, Poland, 60-185
        • Not yet recruiting
        • AIDPORT Sp. z o.o.
      • Warsaw, Poland, 02-776
        • Not yet recruiting
        • Instytut Hematologii i Transfuzjologii w Warszawie
  • Spain
      • Barcelona, Spain, 08908
        • Not yet recruiting
        • Institut Català d'Oncologia - L'Hospitalet
      • Madrid, Spain, 28040
        • Not yet recruiting
        • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Not yet recruiting
        • The Royal Marsden NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • Not yet recruiting
        • King's College Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Not yet recruiting
        • Nottingham City Hospital
      • Plymouth, United Kingdom, Pl6 8DH
        • Not yet recruiting
        • Derriford Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Not yet recruiting
        • University Hospital Southampton NHS Foundation Trust
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Not yet recruiting
        • Mayo Clinic - Scottsdale
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
      • Los Angeles, California, United States, 90059
        • Not yet recruiting
        • University of California, Los Angeles (UCLA) - Medical Center
      • San Francisco, California, United States, 94158
        • Not yet recruiting
        • University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami - Sylvester Cancer Center
      • Sarasota, Florida, United States, 34236
        • Recruiting
        • Florida Cancer Specialists - Sarasota
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic - Rochester
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
      • Rochester, New York, United States, 14618
        • Recruiting
        • University of Rochester
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University (OSU)
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health & Science University (OHSU)
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Not yet recruiting
        • Texas Oncology - DFW (Sammons CC)
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Baylor College of Medicine
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington - Fred Hutchinson Cancer Center (Seattle Cancer Care Alliance)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Froedtert Hospital and the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1a-Monotherapy Dose Escalation (Cohort A1)
LY4584180 monotherapy administered orally
Drug: LY4584180
administered orally
Experimental: Phase 1a-Monotherapy Dose Optimization (Cohort A2)
LY4584180 monotherapy administered orally
Drug: LY4584180
administered orally
Experimental: Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3)
LY4584180 monotherapy administered orally
Drug: LY4584180
administered orally
Experimental: Phase 1b-Dose Expansion-Combination (Cohort B4)
LY4584180 administered orally in combination with rituximab administered through IV infusion
Drug: LY4584180
administered orally
Drug: Rituximab
administered through IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Time Frame: Baseline up to Day 28
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Baseline up to Day 28
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: 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
Baseline up to 3 Years
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
Time Frame: Baseline up to 3 Years
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
Baseline up to 3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180
Time Frame: Baseline to Day 8
PK: Cmax of LY4584180
Baseline to Day 8
PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180
Time Frame: Baseline to Day 8
PK: AUC versus time curve of LY4584180
Baseline to Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

November 7, 2025

First Submitted That Met QC Criteria

November 7, 2025

First Posted (Actual)

November 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27804
  • J6Y-OX-JBFA (Other Identifier: Eli Lilly and Company)
  • 2025-523601-16-00 (Other Identifier: EU CTIS Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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