FiREBOLT: LY4337713 in Adults with FAP-Positive Solid Tumors

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called LY4337713 (the study drug) is a safe and effective option for people who have FAP-positive solid tumors. The study drug is a type of radiotherapy that is intended to target and attach only to FAP. The goal of targeted radiotherapy is to provide selective delivery of radiation doses that can destroy tumor cells.

What is the Condition Being Studied?

Cancers with Fibroblast Activation Protein (FAP) Positive Solid Tumors

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with one of the following forms of cancer with a solid tumor present: adenocarcinoma of the pancreas, HR-positive & HER2-negative breast cancer, HER2-positive breast cancer, triple-negative breast cancer, platinum-resistant or refractory ovarian cancer, gastric adenocarcinoma, colorectal cancer, squamous cell carcinoma or adenocarcinoma esophageal cancer, or cholangiocarcinoma
  • Have clinical or imaging evidence of FAP expression

For more information, contact the study team at dana.a.warren@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

  • Get an intravenous (IV) injection of the study drug either every 4 weeks or every 6 weeks, depending on when you are enrolled
  • Have blood draws and give urine samples
  • Have regular CT or MRI scans

Study Details

Full Title
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)
Principal Investigator
Assistant Professor of Medicine
Protocol Number
IRB: PRO00118353
NCT: NCT07213791
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF