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RecruitingInterventionalPhase 1

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)

NCT ID: NCT07213791Sponsor: Eli Lilly and CompanyLast updated: 2026-06-04

Summary

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.

Arms & interventions

  • DrugLY4337713

    Administered IV.

Outcome measures

Primary

  • Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities

    Time frame: Cycle 1 (28 days)

  • Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)

    Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

    Time frame: Baseline through imaging follow-up, up to 5 years

Secondary

  • Phase 1a: Absorbed Dose Estimates (Gy) in Normal Organs

    Time frame: Baseline through Cycle 4 Day 4 (Cycle = 4 or 6 weeks)

  • Phase 1a: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713

    Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)

  • Phase 1a: PK: Area Under the Concentration Time Curve (AUC) of LY4337713

    Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)

  • Phase 1a: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)

    Time frame: Baseline through imaging follow-up, up to 1 year

  • Phase 1a: Number of Participants with Best Overall Response (BOR)

    Time frame: Baseline through imaging follow-up, up to 1 year

  • Phase 1a and 1b: Duration of Response (DOR)

    Time frame: Baseline through imaging follow-up, up to 5 years

  • Phase 1a and 1b: Time to Response (TTR)

    Time frame: Baseline through imaging follow-up, up to 1 year

  • Phase 1a and 1b: Percentage of Participants with Disease Control Rate (DCR)

    Time frame: Baseline through imaging follow-up, up to 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (20)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

Recruiting

Stanford University Medical Center

Stanford, California, 94305

Recruiting

Biogenix Molecular, LLC

Miami, Florida, 33165

Recruiting

Moffitt

Tampa, Florida, 33612

Not Yet Recruiting

Indiana University (IU) School of Medicine

Indianapolis, Indiana, 46202

Recruiting

United Theranostics

Glen Burnie, Maryland, 21061

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Not Yet Recruiting

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting

BAMF Health Inc.

Grand Rapids, Michigan, 49503

Recruiting

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Not Yet Recruiting

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110

Not Yet Recruiting

New York University (NYU) Clinical Cancer Center

New York, New York, 10016

Not Yet Recruiting

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Not Yet Recruiting

Duke University Medical Center

Durham, North Carolina, 27710

Recruiting

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Recruiting

Texas Oncology - DFW (Sammons CC)

Dallas, Texas, 75246

Not Yet Recruiting

Baylor College of Medicine

Houston, Texas, 77030

Not Yet Recruiting

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin, 53792

Recruiting