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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 approximately 5 years post final administration
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 years post final administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years post final administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058
Maximum tolerated dose (MTD) of [225Ac]-FPI-2059
Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest
Secondary outcome measures
Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1
Pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2059 by measuring changes in clearance, AUC, Cmax, and half-life
Cognitive Therapy
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to the treatment being studied.My scans show a lesion that can be measured for the study.I am fully active or can carry out light work.I do not have a severe illness that would stop me from following the study's requirements.My cancer has spread to my brain.I have not had radiation therapy in the last 28 days.My organs are working well.I have had treatment with radioactive drugs before.I cannot undergo the imaging procedures needed for this study.My cancer is advanced, cannot be removed by surgery, or has come back.I haven't had cancer treatments like chemotherapy or immunotherapy recently.I have not received any vaccines in the last 30 days.My condition worsened after treatment and I can't or won't use standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Expansion
- Group 2: Phase 1 Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently enrolling participants?
"The trial's information on clinicaltrials.gov discloses that it is not currently enrolling patients, although the listed first and last updated dates are November 1st 2022 and October 31st 2022 respectively. Fortunately, there are 2162 other trials actively seeking participants presently."
Answered by AI
Has the FDA sanctioned Phase 1 Dose Escalation?
"In light of the preliminary nature of this first-phase screening, Power assigned a score of 1 to Phase 1 Dose Escalation in terms of safety."
Answered by AI
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