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

Recruiting now · Phase 1

Conditions studied: Ovarian Neoplasms, Breast Neoplasms, Pancreatic Intraductal Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT07213791

Run by

Eli Lilly and Company

People needed

241

Starts

2025-10-22

Expected to finish

2033-03-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
• Stanford University Medical Center — Stanford, California, United States (enrolling)
• Moffitt — Tampa, Florida, United States (enrolling)
• Indiana University (IU) School of Medicine — Indianapolis, Indiana, United States (enrolling)
• United Theranostics — Glen Burnie, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• BAMF Health Inc. — Grand Rapids, Michigan, United States (enrolling)
• New York University (NYU) Clinical Cancer Center — New York, New York, United States (enrolling)
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• Texas Oncology - DFW (Sammons CC) — Dallas, Texas, United States (enrolling)
• University of Wisconsin - Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)
• Erasmus MC — GE Rotterdam, Netherlands
• Maastricht University Medical Center — Maastricht, Netherlands
• Biogenix Molecular, LLC — Miami, Florida, United States
• Stichting Radboud Universitair Medisch Centrum — Nijmegen, Netherlands
• Baylor College of Medicine — Houston, Texas, United States
• Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
• Fudan University Zhongshan Hospital — Shanghai, China
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Universitaetsklinikum Essen — Essen, Germany
• National Cancer Center Hospital East — Chiba, Japan

Full record on ClinicalTrials.gov

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