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Radioisotope Therapy

[225Ac]-FPI-2059 for Solid Cancers

Phase 1
Recruiting
Research Sponsored by Fusion Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial tests if experimental drugs are safe and effective against cancer in humans for the first time.

Who is the study for?
This trial is for adults with certain advanced solid tumors, including pancreatic, colorectal, prostate, stomach cancers and more. Participants must have a tumor that can be measured by RECIST v.1.1 criteria and express NTSR1 as confirmed by imaging after [111In]-FPI-2058 injection. They should have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), adequate organ function, and no effective standard therapy options left.
What is being tested?
[225Ac]-FPI-2059 and [111In]-FPI-2058 are being tested for safety, tolerability, how the body processes them (pharmacokinetics), and where they go in the body (biodistribution) in patients with solid tumors expressing neurotensin receptor 1. This first-in-human Phase 1 trial aims to find out if these treatments are safe to use and how they affect participants' bodies.
What are the potential side effects?
As this is a first-in-human study testing new compounds ([225Ac]-FPI-2059 & [111In]-FPI-2058), specific side effects aren't fully known yet but may include typical reactions related to radiopharmaceuticals such as nausea, fatigue, potential organ toxicity or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 1 Dose ExpansionExperimental Treatment2 Interventions
Group II: Phase 1 Dose EscalationExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

Fusion Pharmaceuticals Inc.Lead Sponsor
5 Previous Clinical Trials
544 Total Patients Enrolled
Joanne Schindler, MD, DVMStudy DirectorFusion Pharmaceuticals Inc.

Media Library

[225Ac]-FPI-2059 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05605522 — Phase 1
Solid Tumors Research Study Groups: Phase 1 Dose Expansion, Phase 1 Dose Escalation
Solid Tumors Clinical Trial 2023: [225Ac]-FPI-2059 Highlights & Side Effects. Trial Name: NCT05605522 — Phase 1
[225Ac]-FPI-2059 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05605522 — Phase 1
~11 spots leftby Jun 2025