NCT03746431

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

A Phase 1 Study of [225Ac]-FPI-1434 Injection in Patients With Locally Advanced or Metastatic Solid Tumours

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Fusion Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This study consists of a Phase 1 portion and a Phase 2 portion. Phase 1 includes the following cohorts: Single dose-ascending cohorts and Multi- dose ascending cohorts of \[225Ac\]-FPI-1434 and Multi- dose ascending cohorts evaluating administration of FPI-1175 (cold antibody), followed by, \[225Ac\]-FPI-1434 (cold + hot), with cycles repeating every 42 days. And Cold Antibody Sub-study evaluating administration of ascending doses of FPI-1175 followed by \[111In\]-FPI-1547. The Phase 2 will evaluate \[111In\]-FPI-1547 and \[225Ac\]-FPI-1434 with or without FPI-1175 in tumour-specific cohorts. The decision to utilize FPI-1175 in the Phase 2 portion of the study will be determined based on Phase 1 data, including safety, tolerability, pharmacokinetic and dosimetry results.

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

Interventions

Type	Name	Description
DRUG	[111In]-FPI-1547 Injection	\[111In\]-FPI-1547 is a targeted radioimmuno-imaging agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Indium-111, a radionuclide. Patients will receive \[111In\]-FPI-1547 Injection of 185 MBq (5 mCi) for imaging.
DRUG	[225Ac]-FPI-1434 Injection multi-dose	\[225Ac\]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive multiple doses of \[225Ac\]-FPI-1434 Injection. Dose is per cohort assignment.
BIOLOGICAL	FPI-1175 Infusion	FPI-1175 is an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody without a radioisotope. Patients will receive FPI-1175 Infusion at a dose per cohort assignment.
DRUG	[225Ac]-FPI-1434 Injection single-dose	\[225Ac\]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive a single dose of \[225\]-FPI-1434 Injection. Dose is per cohort assignment.

Timeline

• Start date: 2019-01-17
• Primary completion: 2025-12-03
• Completion: 2025-12-03
• First posted: 2018-11-19
• Last updated: 2026-01-07

Locations

13 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study