A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fusion Pharmaceuticals Inc.

Criteria

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