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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 1 Dose ExpansionExperimental Treatment2 Interventions
Group II: Phase 1 Dose EscalationExperimental Treatment2 Interventions
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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.
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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.
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