A Phase 1/ 2 Study of (225Ac)-FPI-1434 Injection

ClinicalTrials.gov ID NCT03746431
Sponsor Fusion Pharmaceuticals Inc.
Local PI Ale Berlin

Conditions:

  • Advanced Solid Tumours
  • Endometrial Cancer
  • Cervical Cancer
  • Ovarian Cancer
  • Breast Cancer
  • Triple Negative Breast Cancer (TNBC)
  • HER2-negative Breast Cancer
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Adrenocortical Carcinoma
  • Uveal Melanoma

This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of [225Ac]-FPI-1434 (radioimmuno-therapeutic agent) in patients with solid tumours that demonstrate uptake of [111In]-FPI-1547 (radioimmuno-imaging agent), 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 (radioimmuno-imaging agent).

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