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A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
NCT07213791 · Eli Lilly and Company
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official 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)
About this study
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.
Eligibility criteria
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:
* 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 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.
* 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)
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).
Study design
Enrollment target: 241 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-22
Estimated completion: 2033-03
Last updated: 2026-04-17
Interventions
Drug: LY4337713
Primary outcomes
- • Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities (Cycle 1 (28 days))
- • Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) (Baseline through imaging follow-up, up to 5 years)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (28)
Hoag Memorial Hospital PresbyterianRecruiting
Newport Beach, California, United States
Stanford University Medical CenterRecruiting
Stanford, California, United States
Biogenix Molecular, LLCRecruiting
Miami, Florida, United States
MoffittNot Yet Recruiting
Tampa, Florida, United States
Indiana University (IU) School of MedicineRecruiting
Indianapolis, Indiana, United States
United TheranosticsNot Yet Recruiting
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Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterNot Yet Recruiting
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Barbara Ann Karmanos Cancer InstituteNot Yet Recruiting
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BAMF Health Inc.Recruiting
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Mayo Clinic - RochesterNot Yet Recruiting
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Washington University School of Medicine in St. LouisNot Yet Recruiting
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New York University (NYU) Clinical Cancer CenterNot Yet Recruiting
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David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNot Yet Recruiting
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Duke University Medical CenterRecruiting
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University of PennsylvaniaRecruiting
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Fox Chase Cancer CenterNot Yet Recruiting
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Texas Oncology - DFW (Sammons CC)Not Yet Recruiting
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Baylor College of MedicineNot Yet Recruiting
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University of Wisconsin - Carbone Cancer CenterRecruiting
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Kyoto University HospitalNot Yet Recruiting
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Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)Not Yet Recruiting
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Amsterdam UMC - Locatie VUmcNot Yet Recruiting
Amsterdam, Netherlands
Erasmus MCNot Yet Recruiting
GE Rotterdam, Netherlands
Maastricht University Medical CenterNot Yet Recruiting
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Stichting Radboud Universitair Medisch CentrumNot Yet Recruiting
Nijmegen, Netherlands
Universitair Medisch Centrum UtrechtNot Yet Recruiting
Utrecht, Netherlands