NCT07213791 · Eli Lilly and Company
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
(FiREBOLT)
What this study is about
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 effectiveness of LY4337713.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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.
- 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).
Where
- Newport Beach, California
- Stanford, California
- Miami, Florida
- Tampa, Florida
- Indianapolis, Indiana
- Glen Burnie, Maryland
- Boston, Massachusetts
- Detroit, Michigan
- Grand Rapids, Michigan
- Rochester, Minnesota
- St Louis, Missouri
- New York, New York
And 5 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations