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NCT07213791PHASE1Recruiting

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

Eli Lilly and Company

Start Date

10/22/2025

Completion Date

3/1/2033

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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).

Interventions

DRUG

LY4337713

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Conditions

Ovarian NeoplasmsBreast NeoplasmsPancreatic Intraductal NeoplasmsColorectal NeoplasmsEsophageal NeoplasmsStomach NeoplasmsCholangiocarcinoma

Locations

Hoag Memorial Hospital Presbyterian

Newport Beach, California 92663

United States

Stanford University Medical Center

Stanford, California 94305

United States

Biogenix Molecular, LLC

Miami, Florida 33165

United States

Moffitt

Tampa, Florida 33612

United States

Indiana University (IU) School of Medicine

Indianapolis, Indiana 46202

United States

United Theranostics

Glen Burnie, Maryland 21061

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan 48201

United States

BAMF Health Inc.

Grand Rapids, Michigan 49503

United States

Mayo Clinic - Rochester

Rochester, Minnesota 55905

United States

Washington University School of Medicine in St. Louis

St Louis, Missouri 63110

United States

New York University (NYU) Clinical Cancer Center

New York, New York 10016

United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

Texas Oncology - DFW (Sammons CC)

Dallas, Texas 75246

United States

Baylor College of Medicine

Houston, Texas 77030

United States

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin 53792

United States

Fudan University Zhongshan Hospital

Shanghai, 200032

China

Universitaetsklinikum Essen

Essen, 45147

Germany

National Cancer Center Hospital East

Chiba, 277-8577

Japan

Kyoto University Hospital

Kyoto, 606-8507

Japan

Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

Amsterdam, 1066 CX

Netherlands

Amsterdam UMC - Locatie VUmc

Amsterdam, 1081 HV

Netherlands

Erasmus MC

GE Rotterdam, 3015

Netherlands

Maastricht University Medical Center

Maastricht, 6229 HX

Netherlands

Stichting Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA

Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, 3584CX

Netherlands