RecruitingPhase 1NCT07213791

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

A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

Sponsor

Eli Lilly and Company

Enrollment

241 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms Cholangiocarcinoma Ovarian Neoplasms Stomach Neoplasms Colorectal Neoplasms Pancreatic Intraductal Neoplasms Esophageal Neoplasms

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer treatment called LY4337713 for people with several types of advanced solid tumors whose cancer shows a specific protein called FAP (fibroblast activation protein). Cancer types include pancreatic, breast, ovarian, stomach, colorectal, esophageal, and bile duct cancers. **You may be eligible if...** - Your tumor tests positive for FAP expression - You have one of the eligible cancer types confirmed by biopsy - You have already received prior standard treatments (the exact number depends on your cancer type) - You are reasonably functional (ECOG 0 or 1) - Your kidney function is adequate (creatinine clearance at least 60 mL/min) **You may NOT be eligible if...** - You have active brain or nervous system metastases - You have had previous adoptive T-cell therapy (like CAR-T) - You have significant heart problems, an abnormal heart rhythm on ECG, or urinary tract obstruction - You have previously received whole-body radiation or a similar antibody-drug treatment - You cannot lie flat for imaging scans Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY4337713

Administered IV.

Locations(28)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Stanford University Medical Center

Stanford, California, United States

Biogenix Molecular, LLC

Miami, Florida, United States

Moffitt

Tampa, Florida, United States

Indiana University (IU) School of Medicine

Indianapolis, Indiana, United States

United Theranostics

Glen Burnie, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

BAMF Health Inc.

Grand Rapids, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

New York University (NYU) Clinical Cancer Center

New York, New York, United States

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

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Texas Oncology - DFW (Sammons CC)

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin, United States

Universitaetsklinikum Essen

Essen, Germany

Kyoto University Hospital

Kyoto, Japan

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

Amsterdam, Netherlands

Amsterdam UMC - Locatie VUmc

Amsterdam, Netherlands

Erasmus MC

GE Rotterdam, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Stichting Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

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NCT07213791

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