Save Studies Locally
We can save your selected studies locally in your browser to enhance your experience. This data stays on your device and is not shared with us or third parties. You can clear this data at any time.
A Phase 1/2 Study of [225Ac]-FPI-1434 Injection
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 🇺🇸
Minneapolis, Minnesota, United States
Philadelphia, Pennsylvania 19104, United States
Boston, Massachusetts 02215, United States
Duarte, California 91010, United States
New York, New York 10065, United States
Buffalo, New York 14203, United States
Australia 🇦🇺
Heidelberg, Victoria, Australia
Adelaide, South Australia, Australia
Canada 🇨🇦
H2X 0C1, Montréal, Quebec, Canada
L8V 5C2, Hamilton, Ontario, Canada
Toronto, Ontario, Canada
G1R 2J6, Québec, Quebec, Canada
