A Study of [225Ac]-FPI-2059 in Adult Participants With 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.

Key Inclusion Criteria:Signed ICF prior to initiation of any study-specific proceduresHistologically 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 therapyMeasurable disease per RECIST v.1.1Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Sufficient target expression in at least one measurable lesion as determined by imaging following injection of [111In]-FPI-2058Adequate organ functionTumor tissue (either archival within the last 24 months or fresh biopsy)Key Exclusion Criteria:Previous treatment with any radiopharmaceuticalContraindications to or inability to perform the imaging procedures required in this studyAnti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within certain amount of time prior to administration of the first dose of [111In]-FPI-2058Radiation therapy (RT) within 28 days prior to the first dose of [111In]-FPI-2058Patients with known CNS metastatic diseaseConcurrent severe and/or uncontrolled illness that would limit compliance with study requirementsKnown or suspected allergies or contraindication to the investigational treatmentReceived any type of vaccine within 30 days prior to the first dose of [111In]-FPI-2058