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

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.

This is a first-in-human, Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2058, as well as the pharmacodynamics and preliminary anti-tumour activity of [225Ac]-FPI-2059 in participants with neurotensin receptor 1 (NTSR1)-expressing advanced, metastatic and/or recurrent solid tumours.

The study will employ a 3+3 dose escalation design to identify the recommended phase 2 dose (RP2D) and regimen of [225Ac]-FPI-2059 administered intravenously every 56 days.

After the RP2D for [225Ac]-FPI-2059 is determined, enrolment will continue into an expansion cohort, to confirm the safety and tolerability of the RP2D, as well as to identify any preliminary evidence of efficacy in selected NTSR1-expressing tumour types.

Key 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