Tests LY4337713 in adults with advanced solid tumors that have high FAP protein

Trial details

Who runs it

Eli Lilly and Company

Trial code

NCT07213791EU 2025-521887-37-00

Record updated

4 November 2026

Original 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.Read full original descriptionShow less

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)

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.

Inclusion: 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).

Exclusion: 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.); 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 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).

ClinicalTrials.gov NCT07213791 · EU CTIS 2025-521887-37-00