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Trial Information
Molecule Overview
Fibroblast Activation Protein Radioligand
LY4337713
Phase
1
Recruiting
Recruiting Info

Dose Escalation and Dose Optimization Phase Ia/Ib Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy with LY4337713 in Adult Patients with Select Solid Tumors

Related Resources:
FiREBOLT trial schema
Key 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 ≤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 ≥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 mL/min
Key Exclusion Criteria
  • Have known active central nervous system (CNS) metastases or carcinomatous meningitis
  • Have significant cardiovascular disease
  • Have prolongation of the corrected QTcF >470 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 (eg, 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)
a
Option to enroll patients in indication-specific backfills at cleared dose levels.
b
Safety and preliminary efficacy data will inform dose level and schedule for Phase 1b optimization.
For information on trial enrollment, locations, and more, call 1-877-285-4559.
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