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

NCT ID: NCT07226843

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Follicular Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1b-Dose Expansion-Combination (Cohort B5)

LY4584180 administered orally in combination with rituximab administered through IV infusion

Group Type EXPERIMENTAL

LY4584180

Intervention Type DRUG

administered orally

Rituximab

Intervention Type DRUG

administered through IV infusion

Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B4)

LY4584180 monotherapy administered orally

Group Type EXPERIMENTAL

LY4584180

Intervention Type DRUG

administered orally

Phase 1a-Optional Monotherapy Dose Optimization (Cohort A2)

LY4584180 monotherapy administered orally

Group Type EXPERIMENTAL

LY4584180

Intervention Type DRUG

administered orally

Phase 1a-Monotherapy Dose Escalation (Cohort A1)

LY4584180 monotherapy administered orally

Group Type EXPERIMENTAL

LY4584180

Intervention Type DRUG

administered orally

Interventions

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LY4584180

administered orally

Intervention Type DRUG

Rituximab

administered through IV infusion

Intervention Type DRUG

Eligibility Criteria

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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
* 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 or suspected history of central nervous system involvement
* Has known Cytomegalovirus infection. Participants with negative status are eligible
* Has known hepatitis B or C infection or HIV
* Has significant heart disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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City of Hope

Duarte, California, United States

Site Status

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

San Francisco, California, United States

Site Status

University of Miami - Sylvester Cancer Center

Miami, Florida, United States

Site Status

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Site Status

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

Seattle, Washington, United States

Site Status

Countries

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United States

Central Contacts

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

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Other Identifiers

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J6Y-OX-JBFA

Identifier Type: OTHER

Identifier Source: secondary_id

2025-523601-16-00

Identifier Type: OTHER

Identifier Source: secondary_id

27804

Identifier Type: -

Identifier Source: org_study_id