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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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) * 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 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 sites (20)
CA
- Hoag Memorial Hospital Presbyterian · Newport Beach, CA 92663More trials in Newport Beach
- Stanford University Medical Center · Stanford, CA 94305More trials in Stanford
FL
- Biogenix Molecular, LLC · Miami, FL 33165More trials in Miami
- Moffitt · Tampa, FL 33612More trials in Tampa
IN
- Indiana University (IU) School of Medicine · Indianapolis, IN 46202More trials in Indianapolis
MA
- Massachusetts General Hospital · Boston, MA 02114More trials in Boston
- Beth Israel Deaconess Medical Center · Boston, MA 02215More trials in Boston
MD
- United Theranostics · Glen Burnie, MD 21061More trials in Glen Burnie
MI
- Barbara Ann Karmanos Cancer Institute · Detroit, MI 48201More trials in Detroit
- BAMF Health Inc. · Grand Rapids, MI 49503More trials in Grand Rapids
MN
- Mayo Clinic - Rochester · Rochester, MN 55905More trials in Rochester
MO
- Washington University School of Medicine in St. Louis · St Louis, MO 63110More trials in St Louis
NC
- Duke University Medical Center · Durham, NC 27710More trials in Durham
NY
- New York University (NYU) Clinical Cancer Center · New York, NY 10016More trials in New York
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center · New York, NY 10065More trials in New York
PA
- University of Pennsylvania · Philadelphia, PA 19104More trials in Philadelphia
- Fox Chase Cancer Center · Philadelphia, PA 19111More trials in Philadelphia
TX
- Texas Oncology - DFW (Sammons CC) · Dallas, TX 75246More trials in Dallas
- Baylor College of Medicine · Houston, TX 77030More trials in Houston
WI
- University of Wisconsin - Carbone Cancer Center · Madison, WI 53792More trials in Madison