Recruiting
Phase 1

LY4584180

Sponsor:

Eli Lilly and Company

Code:

NCT07226843

Conditions

Lymphoma, Non-Hodgkin's

Lymphoma, Diffuse Large B-Cell

Follicular Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LY4584180

Rituximab

Study Details

Brief 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.

Conditions

Lymphoma, Non-Hodgkin's

Lymphoma, Diffuse Large B-Cell

Follicular Lymphoma

Study ID

NCT07226843

Start date

Apr 17, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

460 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a-Monotherapy Dose Escalation (Cohort A1)

LY4584180 monotherapy administered orally

experimental: Phase 1a-Monotherapy Dose Optimization (Cohort A2)

LY4584180 monotherapy administered orally

experimental: Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3)

LY4584180 monotherapy administered orally

experimental: Phase 1b-Dose Expansion-Combination (Cohort B4)

LY4584180 administered orally in combination with rituximab administered through IV infusion

Interventions

LY4584180

administered orally

Rituximab

administered through IV infusion

Primary outcome measure

  • 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 [ Time Frame: Baseline up to 3 Years ]
  • To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR) [ Time Frame: Baseline up to 3 Years ]

Central Contacts and Locations

Central contacts

Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Mayo Clinic - Scottsdale

Recruiting

Scottsdale, Arizona, United States, 85259

City of Hope

Recruiting

Duarte, California, United States, 91010

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

University of Miami - Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Florida Cancer Specialists - Sarasota

Recruiting

Sarasota, Florida, United States, 34236

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Columbia University

Recruiting

New York, New York, United States, 10032

University of Rochester

Recruiting

Rochester, New York, United States, 14618

The Ohio State University (OSU)

Recruiting

Columbus, Ohio, United States, 43210

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Texas Oncology - DFW (Sammons CC)

Recruiting

Dallas, Texas, United States, 75246

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

Recruiting

Seattle, Washington, United States, 98195

Froedtert Hospital and the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-06.