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| ID | Type | Description | Link |
|---|---|---|---|
| J6Y-OX-JBFA | Other Identifier | Eli Lilly and Company | |
| 2025-523601-16-00 | Other Identifier | EU CTIS Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a-Monotherapy Dose Escalation (Cohort A1) | Experimental | LY4584180 monotherapy administered orally |
|
| Phase 1a-Monotherapy Dose Optimization (Cohort A2) | Experimental | LY4584180 monotherapy administered orally |
|
| Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3) | Experimental | LY4584180 monotherapy administered orally |
|
| Phase 1b-Dose Expansion-Combination (Cohort B4) | Experimental | LY4584180 administered orally in combination with rituximab administered through IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4584180 | Drug | administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities | Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities | 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 | 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 |
| To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR) | To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR) | Baseline up to 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180 | PK: Cmax of LY4584180 | Baseline to Day 8 |
| PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180 | PK: AUC versus time curve of LY4584180 |
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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:
Has measurable disease
Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Scottsdale | Not yet recruiting | Scottsdale | Arizona | 85259 | United States | |
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| Rituximab | Drug | administered through IV infusion |
|
| Baseline to Day 8 |
| City of Hope |
| Recruiting |
| Duarte |
| California |
| 91010 |
| United States |
| University of California, Los Angeles (UCLA) - Medical Center | Not yet recruiting | Los Angeles | California | 90059 | United States |
| University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center | Not yet recruiting | San Francisco | California | 94158 | United States |
| Colorado Blood Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
| University of Miami - Sylvester Cancer Center | Not yet recruiting | Miami | Florida | 33136 | United States |
| Florida Cancer Specialists - Sarasota | Recruiting | Sarasota | Florida | 34236 | United States |
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic - Rochester | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
| Columbia University | Recruiting | New York | New York | 10032 | United States |
| University of Rochester | Recruiting | Rochester | New York | 14618 | United States |
| The Ohio State University (OSU) | Recruiting | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University (OHSU) | Not yet recruiting | Portland | Oregon | 97239 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37212 | United States |
| Texas Oncology - DFW (Sammons CC) | Recruiting | Dallas | Texas | 75246 | United States |
| Baylor College of Medicine | Not yet recruiting | Houston | Texas | 77030 | United States |
| University of Washington - Fred Hutchinson Cancer Center (Seattle Cancer Care Alliance) | Recruiting | Seattle | Washington | 98195 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
| CHU de Nantes - Hotel-Dieu | Not yet recruiting | Nantes | 44093 | France |
| Institut Curie | Not yet recruiting | Paris | 75005 | France |
| CHU Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie | Not yet recruiting | Pessac | 33604 | France |
| HCL Centre Hospitalier Lyon Sud | Not yet recruiting | Pierre-Bénite | 69495 | France |
| Oncopole Claudius Regaud | Not yet recruiting | Toulouse | 31059 | France |
| Charite Universitaetsmedizin Berlin | Not yet recruiting | Berlin | 10117 | Germany |
| Universitaetsklinikum Koeln (AoeR) | Not yet recruiting | Cologne | 50937 | Germany |
| Universitaetsklinikum Essen | Not yet recruiting | Essen | 45147 | Germany |
| Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet | Not yet recruiting | Frankfurt am Main | 60590 | Germany |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola | Not yet recruiting | Bologna | 40138 | Italy |
| Istituto Europeo di Oncologia | Not yet recruiting | Milan | 20141 | Italy |
| National Cancer Center Hospital East | Not yet recruiting | Chiba | 277-8577 | Japan |
| Okayama University Hospital | Not yet recruiting | Okayama | 700-8558, | Japan |
| Cancer Institute Hospital of JFCR | Not yet recruiting | Tokyo | 135-8550 | Japan |
| Pratia Onkologia Katowice | Not yet recruiting | Katowice | 40-519 | Poland |
| Pratia MCM Krakow | Not yet recruiting | Krakow | 30-727 | Poland |
| AIDPORT Sp. z o.o. | Not yet recruiting | Skorzewo | 60-185 | Poland |
| Instytut Hematologii i Transfuzjologii w Warszawie | Not yet recruiting | Warsaw | 02-776 | Poland |
| Institut Catala d'Oncologia - L'Hospitalet | Not yet recruiting | Barcelona | 08908 | Spain |
| South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz | Not yet recruiting | Madrid | 28040 | Spain |
| King's College Hospital | Not yet recruiting | London | SE5 9RS | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Not yet recruiting | London | SW3 6JJ | United Kingdom |
| Nottingham City Hospital | Not yet recruiting | Nottingham | NG5 1PB | United Kingdom |
| Derriford Hospital | Not yet recruiting | Plymouth | PL6 8DH | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Not yet recruiting | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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