A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
- Conditions
- Lymphoma, Non-Hodgkin'sLymphoma, Diffuse Large B-CellFollicular Lymphoma
- Interventions
- Drug: LY4584180
- Registration Number
- NCT07226843
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 360
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1a-Monotherapy Dose Escalation (Cohort A1) LY4584180 LY4584180 monotherapy administered orally Phase 1a-Optional Monotherapy Dose Optimization (Cohort A2) LY4584180 LY4584180 monotherapy administered orally Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B4) LY4584180 LY4584180 monotherapy administered orally Phase 1b-Dose Expansion-Combination (Cohort B5) LY4584180 LY4584180 administered orally in combination with rituximab administered through IV infusion Phase 1b-Dose Expansion-Combination (Cohort B5) Rituximab LY4584180 administered orally in combination with rituximab administered through IV infusion
- Primary Outcome Measures
Name Time Method Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities Baseline up to Day 28 Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration Baseline up to 3 Years Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR) Baseline up to 3 Years To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180 Baseline to Day 8 PK: Cmax of LY4584180
PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180 Baseline to Day 8 PK: AUC versus time curve of LY4584180
Trial Locations
- Locations (9)
City of Hope
🇺🇸Duarte, California, United States
University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
University of Miami - Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Florida Cancer Specialists - Sarasota
🇺🇸Sarasota, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Oregon Health & Science University (OHSU)
🇺🇸Portland, Oregon, United States
University of Washington - Fred Hutchinson Cancer Center (Seattle Cancer Care Alliance)
🇺🇸Seattle, Washington, United States
City of Hope🇺🇸Duarte, California, United States