Phase 1: testing LY4337713 for Ovarian Neoplasms
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).
Official registry: https://clinicaltrials.gov/study/NCT07213791 · Eli Lilly and Company · enrollment listed as 340
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are LY4337713. The registry lists allocation as randomized. This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread.
They plan to enroll about 340 people at 30 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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)
Interventions: LY4337713
Primary outcome (registry wording): Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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)
Who the registry excludes
- 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)
Public study contact (from the registry)
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
30 listed- Hoag Memorial Hospital Presbyterian — Newport Beach, California (recruiting)
- Stanford University Medical Center — Stanford, California (recruiting)
- Biogenix Molecular, LLC — Miami, Florida (completed)
- Moffitt — Tampa, Florida (recruiting)
- Indiana University (IU) School of Medicine — Indianapolis, Indiana (recruiting)
- United Theranostics — Glen Burnie, Maryland (recruiting)
- Massachusetts General Hospital — Boston, Massachusetts (recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts (not_yet_recruiting)
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan (recruiting)
- BAMF Health Inc. — Grand Rapids, Michigan (recruiting)
- Mayo Clinic - Rochester — Rochester, Minnesota (recruiting)
- Washington University School of Medicine in St. Louis — St Louis, Missouri (recruiting)
+ 10 sites outside the US on the same record
FAQ about this NCT record
Is NCT07213791 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07213791?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07213791?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary