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

RecruitingPhase 1Ages 18 Years - anyAllEli Lilly and Company
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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) * Gastric cancer (adenocarcinoma) * Colorectal cancer (CRC) * Esophageal cancer (squamous cell carcinoma or adenocarcinoma) * Cholangiocarcinoma * Other non- central nervous system (CNS) solid tumors, which have demonstrated FAP uptake via positron emission tomography (PET), * 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 (โ‰ค)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 1 prior line of therapy for metastatic disease, and must have received an ADC unless unavailable, ineligible, or refused. * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy. * Gastric cancer, CRC, esophageal cancer (squamous cell carcinoma or adenocarcinoma), and cholangiocarcinoma: Participants must have received greater than or equal to (โ‰ฅ)1 prior line of systemic therapy for advanced or metastatic disease; this may include, but does not require, prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor. * Other non-CNS solid tumors: Participants must have exhausted, be ineligible for, or refused all standard-of-care therapy appropriate for their disease. * Phase 1b: * Participants must have advanced or metastatic solid tumors and have received โ‰ฅ1 prior line of therapy. * Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1. * Measured creatinine clearance โ‰ฅ60 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).
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What it tests

  • LY4337713
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Where

30 sites
Hoag Memorial Hospital Presbyterian
Newport Beach, United States
Stanford University Medical Center
Stanford, United States
Biogenix Molecular, LLC
Miami, United States
Moffitt
Tampa, United States
Indiana University (IU) School of Medicine
Indianapolis, United States
United Theranostics
Glen Burnie, United States
Massachusetts General Hospital
Boston, United States
Beth Israel Deaconess Medical Center
Boston, United States

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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