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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

In phase 1, cohort 1, the potential impact of pre-dose administration of vofatamab on the dosimetry, PK, safety, and tolerability of [225Ac]-FPI-1966 and [111In]-FPI-1967 will be evaluated. In later phase 1 cohorts, [225Ac]-FPI-1966 will be evaluated at ascending dose levels. Participants will receive [111In]-FPI-1967 during the imaging screening period to assess FGFR3 expression and to determine biodistribution and estimate radiation exposure to critical organs. Once the recommended phase 2 dose (RP2D) or regimen is established and confirmed, three tumour-agnostic expansion cohorts may be initiated in parallel. ;

Study Design

Related Conditions & MeSH terms

Advanced Solid Tumor
Bladder Carcinoma
Breast Cancer
Carcinoma
Colorectal Cancer
Gastric Cancer
Head and Neck Squamous Cell Carcinoma
Liver Cancer
Lung Cancer
Ovarian Cancer
Squamous Cell Carcinoma of Head and Neck
Urinary Bladder Neoplasms

Clinical Trial Details

NCT number	NCT05363605
Study type	Interventional
Source	Fusion Pharmaceuticals Inc.
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	April 20, 2022
Completion date	September 8, 2023

View Details

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