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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524180-20-00 | EU Trial (CTIS) Number | ||
| J6N-MC-JUCA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell malignancies. Participants will have the option to continue taking LY4152199 until the study ends.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Dose Escalation (Cohort A) - DLBCL and FL | Experimental | Escalating doses of LY4152199 administered intravenously (IV) |
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| Phase 1: Dose Optimization (Cohort B1) - DLBCL | Experimental | Two or more doses of LY4152199 (evaluated during dose escalation) administered IV |
|
| Phase 1: Dose Optimization (Cohort B2) - FL | Experimental | Two or more doses of LY4152199 (evaluated during dose escalation) administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4152199 - IV | Drug | Administered by IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199 | Cycle 1 Day 1 through Cycle 2 Day 8 (35 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 - Pharmacokinetics (PK): Area under the Concentration versus Time Curve (AUC) of LY4152199 | Baseline up to approximately 91 weeks | |
| Phase 1- PK: Maximum drug Concentration (Cmax) of LY4152199 | Baseline up to approximately 91 weeks |
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Inclusion Criteria:
Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator.
Participants with select tumor types must have measurable or assessable disease as defined below:
Must be able to comply with inpatient/outpatient treatment, laboratory monitoring, and required clinic visits for the duration of trial participation.
Must have adequate organ function.
Phase 1 Dose Escalation (Cohort A) Participants - Must have histologically confirmed relapsed/refractory B-cell malignancy.
Phase 1 Dose Optimization (Cohort B) Participants
- Must have histologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed from follicular lymphoma (FL).
Exclusion Criteria:
All Participants
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions 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 |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States | |
| University of Colorado Denver - School of Medicine - Anschutz Medical Campus |
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| Phase 1 - Overall Response Rate (ORR): Percentage of Participants with Best Overall Response (BOR) of Partial Response (PR) or Better. | Assessed by the Investigator per disease-specific response criteria as appropriate to disease indication. | Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy |
| Phase 1 - Duration of Response (DOR) | Time between the date of first documented response (PR or better) to the date of first disease progression or death due to any cause, whichever occurs first | Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy |
| Phase 1- Time to Response (TTR) | Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented response (PR or better) | Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy |
| Phase 1 - Progression Free Survival (PFS) | Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented disease progression or death due to any cause, whichever occurs first | Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy |
| Recruiting |
| Aurora |
| Colorado |
| 80045-2559 |
| United States |
| Colorado Blood Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
| Yale University School of Medicine - Yale Cancer Center | Recruiting | New Haven | Connecticut | 06520-8028 | United States |
| The University of Chicago Medical Center (UCMC) | Recruiting | Chicago | Illinois | 60637 | United States |
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
| University of Kansas Cancer Center | Not yet recruiting | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
| University of Michigan Comprehensive Cancer Center | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic - Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| Rutgers Cancer Institute of New Jersey | Not yet recruiting | New Brunswick | New Jersey | 08903 | United States |
| New York University (NYU) Clinical Cancer Center | Recruiting | New York | New York | 10016 | United States |
| Weill Cornell Medicine | Recruiting | New York | New York | 10021 | United States |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Cleveland Clinic | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Abramson Cancer Center | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| University of Texas Southwestern | Not yet recruiting | Dallas | Texas | 75244 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Intermountain Healthcare | Not yet recruiting | Salt Lake City | Utah | 84111 | United States |
| Swedish Cancer Institute (SCI) | Not yet recruiting | Seattle | Washington | 98104 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
| The Alfred Hospital | Not yet recruiting | Melbourne, VIC | 3004 | Australia |
| Linear Clinical Research | Not yet recruiting | Nedlands | 6009 | Australia |
| Lady Davis Institute for Medical Research Jewish General Hospital | Not yet recruiting | Montreal | H3T 1E2 | Canada |
| University Health Network (UHN) - Princess Margaret Cancer Centre | Not yet recruiting | Toronto | M5G 1Z5 | Canada |
| BC Cancer - Vancouver | Not yet recruiting | Vancouver | V5Z 1L3 | Canada |
| Aarhus University Hospital | Not yet recruiting | Aarhus | N 8200 | Denmark |
| Center for Cancer and Organ Diseases - Rigshospitalet | Not yet recruiting | Copenhagen | 2100 | Denmark |
| CHU de Lille - Hopital Claude Huriez | Not yet recruiting | Lille | 59037 | France |
| AP-HP Hopital Saint-Louis | Not yet recruiting | Paris | 75010 | France |
| Charite Universitaetsmedizin Berlin | Not yet recruiting | Berlin | 10117 | Germany |
| LMU Klinikum Muenchen-Campus Grosshadern | Not yet recruiting | München | 80336 | Germany |
| Universitaetsklinikum Muenster | Not yet recruiting | Münster | 48149 | Germany |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola | Not yet recruiting | Bologna | 40138 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Not yet recruiting | Naples | 80131 | Italy |
| Istituto Clinico Humanitas | Not yet recruiting | Rozzano | 20089 | Italy |
| National Cancer Center Hospital East | Not yet recruiting | Chiba | 277-8577 | Japan |
| Okayama University Hospital | Not yet recruiting | Okayama | 700-8558, | Japan |
| The Cancer Institute Hospital of JFCR | Not yet recruiting | Tokyo | 135-8550 | Japan |
| Pratia MCM Krakow | Not yet recruiting | Krakow | 30-727 | Poland |
| AIDPORT Sp. z o.o. | Not yet recruiting | Skorzewo | 60-185 | Poland |
| Seoul National University Hospital | Not yet recruiting | Seoul | 03080 | South Korea |
| Asan Medical Center | Not yet recruiting | Seoul | 05505 | South Korea |
| Hospital Universitario Vall d'Hebron | Not yet recruiting | Barcelona | 08035 | Spain |
| 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 |
| Leeds Teaching Hospitals NHS Trust | Not yet recruiting | Leeds | LS9 7TF | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Not yet recruiting | Oxford | OX3 9DU | United Kingdom |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008258 | Waldenstrom Macroglobulinemia |
| D020522 | Lymphoma, Mantle-Cell |
| 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 |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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