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A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours
Trial Status: administratively complete
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05605522.
Locations matching your search criteria
United States
Kentucky
Lexington
University of Kentucky/Markey Cancer Center
Status: Temporarily closed to accrual
Name Not Available
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Approved
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
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.
