A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy 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 Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
City of Hope
Duarte, California 91010
Duarte, California 91010
Colorado Blood Cancer Institute
Denver, Colorado 80218
Denver, Colorado 80218
Florida Cancer Specialists - Sarasota
Sarasota, Florida 34236
Sarasota, Florida 34236
Emory University Hospital
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Columbia University
New York, New York 10032
New York, New York 10032
University of Rochester
Rochester, New York 14618
Rochester, New York 14618
The Ohio State University (OSU)
Columbus, Ohio 43210
Columbus, Ohio 43210
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Vanderbilt University Medical Center
Nashville, Tennessee 37212
Nashville, Tennessee 37212
Texas Oncology - DFW (Sammons CC)
Dallas, Texas 75246
Dallas, Texas 75246
University of Washington - Fred Hutchinson Cancer Center (Seattle Cancer Care Alliance)
Seattle, Washington 98195
Seattle, Washington 98195
More Details
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
LillyTrials@Lilly.com