Study Title
A Phase 1/2 Study of [225Ac]-FPI-1434 Injection
Study Details
Description:
This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical trial designed to investigate safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumour activity of [111In]-FPI-1547 Injection (radioimmuno-imaging agent) and [225Ac]-FPI-1434 Injection (radioimmuno-therapeutic) and to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of repeat doses of [225Ac]-FPI-1434 Injection in patients with solid tumours that demonstrate uptake of [111In]-FPI-1547. The study consists of a Phase 1 portion that includes dose ascending cohorts (single and multi-dosing administration with/without cold antibody), a Cold Antibody Sub-Study, and a Phase 2 portion that includes tumour-specific cohorts.
Sponsor:
Fusion Pharmaceuticals, Inc.Contacts:
Julia Kazakin (Medical Monitor)clinicaltrials@fusionpharma.com
(888) 506-4215
Government Study Link:
NCT03746431 - Click here to see study onClinicalTrials.gov
- Measurable or evaluable disease in accordance with RECIST 1.1.
- Life expectancy of greater than 3 months as judged by the treating physician
- Pathologically documented, definitively diagnosed, advanced solid tumour
- Available tumour tissue (either archival or fresh biopsy) for IGF-1R immunohistochemistry.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Systemic therapeutic radiopharmaceutical within 6 months prior to enrollment into this study.
- Residual CTCAE ≥ Grade 2 side effects of prior therapy, with the exception of residual grade 2 alopecia.
- Contraindications to or inability to perform the required imaging procedures in this study
- Prior organ transplantation, including stem cell transplantation.
Patient Education
Patient Education Not Yet Provided
Locations
United States
Australia