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Clinical Trials in China / NCT07213791
Recruiting Phase 1

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

NCT07213791 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2025-10-22
Last updated
2026-09-04

Condition(s) studied

Ovarian NeoplasmsBreast NeoplasmsPancreatic Intraductal NeoplasmsColorectal NeoplasmsEsophageal NeoplasmsStomach NeoplasmsCholangiocarcinoma

Investigational drug(s) / intervention(s)

LY4337713

LY4337713: Administered IV.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
Stanford University Medical Center Stanford California Recruiting
Biogenix Molecular, LLC Miami Florida Completed
Moffitt Tampa Florida Recruiting
Indiana University (IU) School of Medicine Indianapolis Indiana Recruiting
United Theranostics Glen Burnie Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Not Yet Recruiting
Barbara Ann Karmanos Cancer Institute Detroit Michigan Recruiting
BAMF Health Inc. Grand Rapids Michigan Recruiting
Mayo Clinic - Rochester Rochester Minnesota Not Yet Recruiting
Washington University School of Medicine in St. Louis St Louis Missouri Recruiting
New York University (NYU) Clinical Cancer Center New York New York Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York New York Recruiting
Duke University Medical Center Durham North Carolina Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Recruiting
Texas Oncology - DFW (Sammons CC) Dallas Texas Recruiting
Baylor College of Medicine Houston Texas Not Yet Recruiting
University of Wisconsin - Carbone Cancer Center Madison Wisconsin Recruiting
Fudan University Zhongshan Hospital Shanghai China Not Yet Recruiting
Universitaetsklinikum Essen Essen Germany Not Yet Recruiting
National Cancer Center Hospital East Chiba Japan Not Yet Recruiting
Kyoto University Hospital Kyoto Japan Not Yet Recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL) Amsterdam Netherlands Not Yet Recruiting
Amsterdam UMC - Locatie VUmc Amsterdam Netherlands Not Yet Recruiting
Erasmus MC GE Rotterdam Netherlands Not Yet Recruiting
Maastricht University Medical Center Maastricht Netherlands Not Yet Recruiting
Stichting Radboud Universitair Medisch Centrum Nijmegen Netherlands Not Yet Recruiting
Universitair Medisch Centrum Utrecht Utrecht Netherlands Not Yet Recruiting

More Eli Lilly and Company trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07213791 on ClinicalTrials.gov ↗ ← All trials in China