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Trial Summary

This is a first-in-human Phase 1, non-randomized, multi-center, 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.

Acronym:

FPX-01-01

ACTRN/NCT /ethics:

NCT03746431

Scientific title:

A Phase 1 Study of [225Ac]-FPI-1434 Injection in Patients With Advanced Solid Tumours

Sponsor / Cooperative group:

Fusion Pharmaceuticals

Trial & Patient Characteristics

Cancer TypeAll cancers
Trial TypeTreatment
PhasePhase I
Age Range18 years and older
SexBoth
Tumour Stream Advanced Solid Tumors
Cancer StageLocally Recurrent or Locally Advanced
Anticipated Start Date2019-01-17
Anticipated End Date2021-01-31

Participating Hospitals

HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
Emailanne.milton@sa.gov.au
Phone08 7074 2342
Principal InvestigatorProfessor Michael Brown
Recruitment StatusRecruiting