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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
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

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongshan Hospital,Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaNot yet recruiting
Universitaetsklinikum Essen (AoR)
Coordinator of this site? Confirm its status
EssenGermanyNot yet recruiting
National Cancer Center Hospital East
Coordinator of this site? Confirm its status
ChibaJapanNot yet recruiting
Kyoto University Hospital
Coordinator of this site? Confirm its status
KyotoJapanNot yet recruiting
Amsterdam UMC Stichting
Coordinator of this site? Confirm its status
AmsterdamNetherlandsNot yet recruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Coordinator of this site? Confirm its status
AmsterdamNetherlandsNot yet recruiting
Academisch Ziekenhuis Maastricht
Coordinator of this site? Confirm its status
MaastrichtNetherlandsNot yet recruiting
Radboud universitair medisch centrum Stichting
Coordinator of this site? Confirm its status
NijmegenNetherlandsNot yet recruiting
Universitair Medisch Centrum Utrecht
Coordinator of this site? Confirm its status
UtrechtNetherlandsNot yet recruiting
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesNot yet recruiting
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Texas Oncology - DFW (Sammons CC)
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Barbara Ann Karmanos Cancer Institute
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting
Duke University Medical Center
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
United Theranostics
Coordinator of this site? Confirm its status
Glen BurnieUnited StatesRecruiting
BAMF Health Inc.
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
Baylor College of Medicine
Coordinator of this site? Confirm its status
HoustonUnited StatesNot yet recruiting
Indiana University (IU) School of Medicine
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center
Coordinator of this site? Confirm its status
MadisonUnited StatesRecruiting
Biogenix Molecular, LLC
Coordinator of this site? Confirm its status
MiamiUnited StatesCompleted
Hoag Memorial Hospital Presbyterian
Coordinator of this site? Confirm its status
Newport BeachUnited StatesRecruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
New York University (NYU) Clinical Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Fox Chase Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Mayo Clinic - Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
Stanford University Medical Center
Coordinator of this site? Confirm its status
StanfordUnited StatesRecruiting
Washington University School of Medicine in St. Louis
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Moffitt
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.