NCT07213791RecruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 7 Oct 2025
- Start date
- 22 Oct 2025
- Primary completion date
- Jul 2028
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT07213791
- EU CT number
- 2025-521887-37-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 340
- From 22 Oct 2025 to the primary completion date, Jul 2028
- 29 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.)
Other illness
- Have significant cardiovascular disease
Lab values
- Have prolongation of the corrected QTcF \>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT/(RR0.33)
Other
- Have known active central nervous system (CNS) metastases or carcinomatous meningitis.
- Have evidence of ongoing and untreated urinary tract obstruction
- 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).
Who the study is looking for
- 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)
- Gastric cancer (adenocarcinoma)
- Colorectal cancer (CRC)
- Esophageal cancer (squamous cell carcinoma or adenocarcinoma)
- Cholangiocarcinoma
- Other non- central nervous system (CNS) solid tumors, which have demonstrated FAP uptake via positron emission tomography (PET),
- 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 1 prior line of therapy for metastatic disease, and must have received an ADC unless unavailable, ineligible, or refused.
- Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.
- Gastric cancer, CRC, esophageal cancer (squamous cell carcinoma or adenocarcinoma), and cholangiocarcinoma: Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; this may include, but does not require, prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.
- Other non-CNS solid tumors: Participants must have exhausted, be ineligible for, or refused all standard-of-care therapy appropriate for their disease.
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Chiba | Japan | Not yet recruiting |
| Kyoto University Hospital Coordinator of this site? Confirm its status | Kyoto | Japan | Not yet recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Not yet recruiting |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Not yet recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Texas Oncology - DFW (Sammons CC) Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Barbara Ann Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| United Theranostics Coordinator of this site? Confirm its status | Glen Burnie | United States | Recruiting |
| BAMF Health Inc. Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| Indiana University (IU) School of Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Biogenix Molecular, LLC Coordinator of this site? Confirm its status | Miami | United States | Completed |
| Hoag Memorial Hospital Presbyterian Coordinator of this site? Confirm its status | Newport Beach | United States | Recruiting |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| New York University (NYU) Clinical Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Stanford University Medical Center Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
| Washington University School of Medicine in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Moffitt Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.