NCT05363605

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

A Phase 1/2 Study of [225Ac]-FPI-1966, [111In]-FPI-1967, and Vofatamab in Participants With FGFR3-expressing Advanced, Inoperable, Metastatic and/or Recurrent Solid Tumours

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Fusion Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Solid Tumor
• Head and Neck Squamous Cell Carcinoma
• Bladder Carcinoma
• Susceptible FGFR3 Genetic Alterations
• FGFR3
• FGFR3 Overexpression
• FGFR3 Receptor
• FGFR3 Protein Overexpression
• Ovarian Cancer
• Colorectal Cancer
• Breast Cancer
• Liver Cancer
• Lung Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	[225Ac]-FPI-1966	\[225Ac\]-FPI-1966 is a targeted alpha therapeutic that consists of vofatamab, a bifunctional chelate, and actinium-225, an alpha particle emitting radionuclide. In Phase 1, the dose depends on cohort assignment. In Phase 2, the RP2D regimen will be administered.
DRUG	[111In]-FPI-1967	\[111In\]-FPI-1967 is an imaging agent that consists of vofatamab, a bifunctional chelate and indium-111 radionuclide. Participants will receive \[111In\]-FPI-1967 Injection of 185 MBq for imaging.
BIOLOGICAL	vofatamab	Vofatamab is a Fibroblast Growth Factor Receptor 3 (FGFR3)-targeting human monoclonal antibody without a radioisotope. In Phase 1, the dose depends on cohort assignment. In Phase 2, if pre-dosing with vofatamab is indicated, the RP2D regimen will be administered.

Timeline

• Start date: 2022-04-20
• Primary completion: 2023-09-08
• Completion: 2023-09-08
• First posted: 2022-05-06
• Last updated: 2023-12-19

Locations

6 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study