Fusion - FPX-01-01 | Clinical Research Studies Listing

Build status - In Progress

Recruiting

18 years - 99 years

All

Phase 1

5 participants needed

1 Location

Brief description of study

A first-in-man Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics of [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection and to establish the maximum tolerated dose of a single [225Ac]-FPI-1434 Injection in patients with solid tumours with demonstrated tumour uptake of [111In]-FPI-1547. Includes a sub-study of FPI-1175 to measure its effect on the diagnostic capabilities of [111In]-FPI-1547

The research team will work closely with colleagues in the Phase I oncology group at Penn Medicine treating solid tumors. Most subjects will be getting treatment in the University of Pennsylvania Health System. Screening will be carried out by the Phase I and nuclear medicine groups and nuclear medicine study team as necessary.

Detailed description of study

Participants will complete the following research procedures:

• Blood tests, urine tests, physical examination, ECGs, a biopsy and scans of your cancer (if you have not recently had either)

• An injection of the imaging study drug [111In] -FPI-1547 followed by four imaging scans over the course of one week

• An injection of the treatment study drug [225Ac]-FPI-1434

• Follow-up visits (in person or over the phone) which include a review of medications, how you are feeling

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Solid tumors,first-in-man
Age: 18 years - 99 years
Gender: All

Updated on 04 Aug 2024. Study ID: 842694

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