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Набира участници Фаза 1 NCT07213791

A Study of LY4337713 in Participants With FAP-Positive Solid Tumors

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Ovarian Neoplasms Breast Neoplasms Pancreatic Intraductal Neoplasms Colorectal Neoplasms Esophageal Neoplasms Stomach Neoplasms Cholangiocarcinoma

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
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.
Кой може да участва
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 * Gastric cancer (adenocarcinoma) * Colorectal cancer (CRC) * Esophageal cancer (squamous cell carcinoma or adenocarcinoma) * Cholangiocarcinoma * Must have received prior treatments as indicated below: * Phase 1a * Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease. * HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4/6 inhibitor. * HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available). * TNBC: Participants must have received at least 2 lines of therapy for metastatic disease. * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy. * Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor. * Phase 1b: * Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy. * 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: * Have known active central nervous system (CNS) metastases or carcinomatous meningitis. * Have significant cardiovascular disease * Have prolongation of the corrected QTcF \>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT/(RR0.33) * Have evidence of ongoing and untreated urinary tract obstruction * Had previous hemi- or total-body radiation. * Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \[CAR-T therapy, T-cell receptor \[TCR\] therapy, etc.) * Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).
Интервенции
LY4337713
DRUG
Места на провеждане 28
Германия (1)
Universitaetsklinikum Essen
Essen
NOT_YET_RECRUITING
Япония (1)
Kyoto University Hospital
Kyoto
NOT_YET_RECRUITING
Нидерландия (6)
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
Amsterdam
NOT_YET_RECRUITING
Amsterdam UMC - Locatie VUmc
Amsterdam
NOT_YET_RECRUITING
Erasmus MC
GE Rotterdam
NOT_YET_RECRUITING
Maastricht University Medical Center
Maastricht
NOT_YET_RECRUITING
Stichting Radboud Universitair Medisch Centrum
Nijmegen
NOT_YET_RECRUITING
Universitair Medisch Centrum Utrecht
Utrecht
NOT_YET_RECRUITING
САЩ (20)
Massachusetts General Hospital
Boston , Massachusetts
Beth Israel Deaconess Medical Center
Boston , Massachusetts
NOT_YET_RECRUITING
Texas Oncology - DFW (Sammons CC)
Dallas , Texas
NOT_YET_RECRUITING
Barbara Ann Karmanos Cancer Institute
Detroit , Michigan
NOT_YET_RECRUITING
Duke University Medical Center
Durham , North Carolina
United Theranostics
Glen Burnie , Maryland
NOT_YET_RECRUITING
BAMF Health Inc.
Grand Rapids , Michigan
Baylor College of Medicine
Houston , Texas
NOT_YET_RECRUITING
Indiana University (IU) School of Medicine
Indianapolis , Indiana
University of Wisconsin - Carbone Cancer Center
Madison , Wisconsin
Biogenix Molecular, LLC
Miami , Florida
New York University (NYU) Clinical Cancer Center
New York , New York
NOT_YET_RECRUITING
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York , New York
NOT_YET_RECRUITING
Hoag Memorial Hospital Presbyterian
Newport Beach , California
University of Pennsylvania
Philadelphia , Pennsylvania
Fox Chase Cancer Center
Philadelphia , Pennsylvania
NOT_YET_RECRUITING
Mayo Clinic - Rochester
Rochester , Minnesota
NOT_YET_RECRUITING
Washington University School of Medicine in St. Louis
St Louis , Missouri
NOT_YET_RECRUITING
Stanford University Medical Center
Stanford , California
Moffitt
Tampa , Florida
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.10.2025
Крайна дата
01.03.2033
Регистрационен номер
NCT07213791
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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