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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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)
Tolerability and Dosimetry of Radioligand Therapy with LY4337713 in Adults
with FAP-Positive Solid Tumors (FiREBOLT)
Principal Investigator
Aman
Opneja
Protocol Number
PRO00118353
NCT ID
NCT07213791
Phase
I
Enrollment Status
Pending Open to Enrollment