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| ID | Type | Description | Link |
|---|---|---|---|
| J6K-OX-JSFA | Other Identifier | Eli Lilly and Company |
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This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4337713 (Cohort A1) | Experimental | Escalating doses of LY4337713 administered intravenously (IV). |
|
| LY4337713 (Cohort A2) | Experimental | Two or more dose regimens of LY4337713 (evaluated during dose escalation) administered IV. |
|
| Experimental: LY4337713 (Cohort B) | Experimental | Tumor specific cohort will receive LY4337713 administered IV. |
|
| Experimental LY4337713 (Cohort C) | Experimental | Tumor specific cohort will receive LY4337713 administered IV. |
|
| Experimental: LY4337713 (Cohort D) | Experimental | Tumor specific cohort will receive LY4337713 administered IV. |
|
| LY4337713 (Cohort E) | Experimental | Tumor specific cohort will receive LY4337713 administered IV. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4337713 | Drug | Administered IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities | Cycle 1 (28 days) | |
| Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) | Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) | Baseline through imaging follow-up, up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Absorbed Dose Estimates (Gy) in Normal Organs | Baseline through Cycle 4 Day 4 (Cycle = 4 or 6 weeks) | |
| Phase 1a: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713 | Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks) |
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Inclusion Criteria:
Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment
Must have histologically or cytologically confirmed diagnosis of one of the following:
Adenocarcinoma of the pancreas
Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer
HER2-positive breast cancer
Triple negative breast cancer (TNBC)
Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)
Other solid tumors
Must have received prior treatments as indicated below:
Phase 1a
Phase 1b:
Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
Measured creatinine clearance ≥60 milliliters per minute (mL/min)
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Recruiting | Newport Beach | California | 92663 | United States | |
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| Label | URL |
|---|---|
| Link to Lilly Trials | View source |
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|
| Phase 1a: PK: Area Under the Concentration Time Curve (AUC) of LY4337713 | Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks) |
| Phase 1a: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) | Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Baseline through imaging follow-up, up to 1 year |
| Phase 1a: Number of Participants with Best Overall Response (BOR) | Best response recorded from the start of study treatment until the earliest of objective disease progression or start of new anticancer therapy, per RECIST v1.1. | Baseline through imaging follow-up, up to 1 year |
| Phase 1a and 1b: Duration of Response (DOR) | Time between the date of first documented response of CR or PR to the date of first disease progression, as assessed by the investigator per RECIST v1.1 or death due to any cause, whichever occurs first. | Baseline through imaging follow-up, up to 5 years |
| Phase 1a and 1b: Time to Response (TTR) | Time from first dose date to the date of first documented response of CR or PR | Baseline through imaging follow-up, up to 1 year |
| Phase 1a and 1b: Percentage of Participants with Disease Control Rate (DCR) | Percentage participants who achieved a BOR of CR, PR, or stable disease (SD), per RECIST v1.1 | Baseline through imaging follow-up, up to 1 year |
| Stanford University Medical Center |
| Recruiting |
| Stanford |
| California |
| 94305 |
| United States |
| Biogenix Molecular, LLC | Recruiting | Miami | Florida | 33165 | United States |
| Moffitt | Recruiting | Tampa | Florida | 33612 | United States |
| Indiana University (IU) School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
| United Theranostics | Recruiting | Glen Burnie | Maryland | 21061 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| BAMF Health Inc. | Recruiting | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic - Rochester | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine in St. Louis | Not yet recruiting | St Louis | Missouri | 63110 | United States |
| New York University (NYU) Clinical Cancer Center | Not yet recruiting | New York | New York | 10016 | United States |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
| Texas Oncology - DFW (Sammons CC) | Not yet recruiting | Dallas | Texas | 75246 | United States |
| Baylor College of Medicine | Not yet recruiting | Houston | Texas | 77030 | United States |
| University of Wisconsin - Carbone Cancer Center | Recruiting | Madison | Wisconsin | 53792 | United States |
| Fudan University Zhongshan Hospital | Not yet recruiting | Shanghai | 200032 | China |
| Universitaetsklinikum Essen | Not yet recruiting | Essen | 45147 | Germany |
| National Cancer Center Hospital East | Not yet recruiting | Chiba | 277-8577 | Japan |
| Kyoto University Hospital | Not yet recruiting | Kyoto | 606-8507 | Japan |
| Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL) | Not yet recruiting | Amsterdam | 1066 CX | Netherlands |
| Amsterdam UMC - Locatie VUmc | Not yet recruiting | Amsterdam | 1081 HV | Netherlands |
| Erasmus MC | Not yet recruiting | GE Rotterdam | 3015 | Netherlands |
| Maastricht University Medical Center | Not yet recruiting | Maastricht | 6229 HX | Netherlands |
| Stichting Radboud Universitair Medisch Centrum | Not yet recruiting | Nijmegen | 6525 GA | Netherlands |
| Universitair Medisch Centrum Utrecht | Not yet recruiting | Utrecht | 3584CX | Netherlands |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| D000077779 | Pancreatic Intraductal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
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