A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours
This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of \[225Ac\]-FPI-2059 and \[111In\]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.
• Signed ICF prior to initiation of any study-specific procedures
• Histologically and/or cytologically confirmed solid tumor that is metastatic or locally advanced, inoperable, or recurrent. Solid tumors indications may include PDAC, CRC, NED prostate cancer, gastric cancer, SCCHN, and Ewing sarcoma.
• Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the patient refuses standard therapy
• Measurable disease per RECIST v.1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Sufficient target expression in at least one measurable lesion as determined by imaging following injection of \[111In\]-FPI-2058
• Adequate organ function
• Tumor tissue (either archival within the last 24 months or fresh biopsy)