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RecruitingInterventionalPhase 1

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

NCT ID: NCT07226843Sponsor: Eli Lilly and CompanyLast updated: 2026-06-04

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.

Arms & interventions

  • DrugLY4584180

    administered orally

  • DrugRituximab

    administered through IV infusion

Outcome measures

Primary

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

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

    Time frame: 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

    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

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

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

    Time frame: Baseline up to 3 Years

Secondary

  • Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180

    Time frame: Baseline to Day 8

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

    Time frame: Baseline to Day 8

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (21)

Mayo Clinic - Scottsdale

Scottsdale, Arizona, 85259

Not Yet Recruiting

City of Hope

Duarte, California, 91010

Recruiting

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

Los Angeles, California, 90059

Not Yet Recruiting

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

San Francisco, California, 94158

Not Yet Recruiting

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Recruiting

University of Miami - Sylvester Cancer Center

Miami, Florida, 33136

Not Yet Recruiting

Florida Cancer Specialists - Sarasota

Sarasota, Florida, 34236

Recruiting

Emory University Hospital

Atlanta, Georgia, 30322

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Not Yet Recruiting

Columbia University

New York, New York, 10032

Recruiting

University of Rochester

Rochester, New York, 14618

Recruiting

The Ohio State University (OSU)

Columbus, Ohio, 43210

Recruiting

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239

Not Yet Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

Recruiting

Texas Oncology - DFW (Sammons CC)

Dallas, Texas, 75246

Not Yet Recruiting

Baylor College of Medicine

Houston, Texas, 77030

Not Yet Recruiting

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

Seattle, Washington, 98195

Recruiting

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Not Yet Recruiting