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

Lilly

Status and phase: Not yet enrolling; Phase 1

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

Treatments: Drug: Rituximab; Drug: LY4584180

Study type: Interventional

Funder types: Industry

Identifiers

NCT07226843

27804

J6Y-OX-JBFA (Other Identifier)

2025-523601-16-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 4 patient groups

Phase 1a-Monotherapy Dose Escalation (Cohort A1)

Experimental group

Description:

LY4584180 monotherapy administered orally

Treatment:

Drug: LY4584180

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

Experimental group

Description:

LY4584180 monotherapy administered orally

Treatment:

Drug: LY4584180

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

Experimental group

Description:

LY4584180 monotherapy administered orally

Treatment:

Drug: LY4584180

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

Experimental group

Description:

LY4584180 administered orally in combination with rituximab administered through IV infusion

Treatment:

Drug: LY4584180

Drug: Rituximab