A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours
Megadott ok: Sponsor reprioritization of active trials.
Key facts
- Where
- Birmingham, Duarte, Glen Burnie, Lexington, Newport Beach, Omaha és St Louis, Egyesült ÁllamokSee the 7 sites
- Phase
- 1. fázis
Where in Egyesült Államok
- University of Alabama At Birmingham HospitalBirmingham, Egyesült ÁllamokNo longer taking part
- City of Hope Medical CenterDuarte, Egyesült ÁllamokNo longer taking part
- Advanced Molecular Imaging and TherapyGlen Burnie, Egyesült ÁllamokNo longer taking part
- University of KentuckyLexington, Egyesült ÁllamokNo longer taking part
- Hoag Family Cancer InstituteNewport Beach, Egyesült ÁllamokNo longer taking part
- XCancer Omaha / Urology Cancer CenterOmaha, Egyesült ÁllamokNo longer taking part
- Washington UniversitySt Louis, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- 3B Pharmaceuticals GmbH
- Trial code
- NCT05605522
- Record updated
- 2025. augusztus 24.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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).
Exclusion: Previous treatment with any radiopharmaceutical; 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; Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements; Received any type of vaccine within 30 days prior to the first dose of [111In]-FPI-2058; Patients with known CNS metastatic disease; Known or suspected allergies or contraindication to the investigational treatment; Contraindications to or inability to perform the imaging procedures required in this study.