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

Inclusion Criteria

• 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) Key

Exclusion Criteria

• Previous treatment with any radiopharmaceutical
• Contraindications to or inability to perform the imaging procedures required in this study
• Anti-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-2058
• Radiation therapy (RT) within 28 days prior to the first dose of [111In]-FPI-2058
• Patients with known CNS metastatic disease
• Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements
• Known or suspected allergies or contraindication to the investigational treatment
• Received any type of vaccine within 30 days prior to the first dose of [111In]-FPI-2058