TheranosticTrials.org
Fusion Pharmaceuticals, Inc.

Clinical Trial · NCT05363605

A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours

Overview

This first-in-human study evaluates safety, tolerability and distribution of \[225Ac\] FPI-1966, \[111In\]-FPI-1967, and vofatamab in patients with FGFR3-expressing solid tumors.

Sponsor

Fusion Pharmaceuticals, Inc.

Phase

Phase 1/2

Contacts

Julia Kazakin, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT05363605

Drug / Compound

FPI-1966

Isotope(s):
Target(s):
  • No Explicit Target
Ligand Class: Antibodies

FPI-1967

Isotope(s):
Target(s):
  • No Explicit Target
Ligand Class: Antibodies

Eligibility

Inclusion

  • Measurable disease per RECIST v. 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, heart, liver, and kidney functionKey
  • Available tumour tissue (archival or fresh biopsy)
  • Refractory to all standard treatments, or for whom standard treatment is not available, or tolerable, or is contraindicated, or the participant refuses standard therapy
  • Histologically and/or cytologically documented diagnosis of locally advanced, inoperable, or metastatic solid tumours

Exclusion

  • Prior systemic radiopharmaceutical therapy within six months prior to the first dose of \[111In\]-FPI-1967
  • Concurrent serious co-morbidities that could limit participants' full participation and compliance
  • Prior radiation therapy (RT) to bone marrow \> 20 Gy
  • RT within 30 days prior to the first dose of \[111In\]-FPI-1967
  • Prior anti-cancer treatment (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents) within a certain amount of time prior to administration of the first dose of \[111In\]-FPI-1967

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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