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Fusion Pharmaceuticals, Inc.

Clinical Trial · NCT03746431

A Phase 1/2 Study of [225Ac]-FPI-1434 Injection

Overview

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.

Phase

Phase 1

Contacts

Julia Kazakin (Medical Monitor)

clinicaltrials@fusionpharma.com

(888) 506-4215

ClinicalTrials.gov

NCT03746431

Drug / Compound

Isotope(s):
Target(s):

Educational Video

Eligibility

Inclusion

  • 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

Exclusion

  • 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.

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