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Radioimmunotherapy
[225Ac]-FPI-1434 for Cancer
Phase 1 & 2
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
Pathologically documented, definitively diagnosed, advanced solid tumour that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy.
Measurable or evaluable disease in accordance with RECIST 1.1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately one year post final [225ac]-fpi-1434 injection.
Awards & highlights
Study Summary
This trial is designed to study the safety and effectiveness of two different injectable treatments for solid tumors, in order to establish a maximum tolerated dose and/or recommended Phase 2 dose.
Who is the study for?
This trial is for adults with certain advanced solid tumors, including specific types of breast, cervical, ovarian cancer and more. Participants must have a life expectancy over 3 months, measurable disease after standard treatments fail or are unsuitable, good organ function and performance status. They can't join if they've had extensive radiation to bone marrow recently, uncontrolled brain metastases or other active cancers within the last 3 years.Check my eligibility
What is being tested?
The study tests [225Ac]-FPI-1434 Injection's safety and effectiveness in patients whose tumors absorb another agent ([111In]-FPI-1547) used for imaging. It aims to find the highest dose patients can tolerate without severe side effects (MTD) and suggest a Phase 2 dose (RP2D).See study design
What are the potential side effects?
Potential side effects include reactions related to radioimmuno therapy such as nausea, fatigue, blood count changes that could increase infection risk or cause bleeding problems. Organ-specific inflammation might occur due to radiation exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer does not respond to standard treatments, or I cannot or choose not to receive them.
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My cancer can be measured or evaluated by standard criteria.
Select...
I am fully active or can carry out light work.
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My cancer is one of the specified types and is advanced, inoperable, or has returned.
Select...
My cancer can be measured and hasn't responded to standard treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately one year post final [225ac]-fpi-1434 injection.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately one year post final [225ac]-fpi-1434 injection.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cold Antibody Sub-Study: Changes in radiation dose estimates for selected tissues, organs and whole body both for [111In]-FPI-1547 and [225Ac]-FPI-1434 Injection at various dose levels following FPI-1175 Infusion.
Cold Antibody Sub-Study: Changes in uptake of [111In]-FPI-1547 Injection following FPI-1175 Infusion in selected regions of interest on SPECT/CT images.
Dose Escalation: Changes in electrocardiogram (ECG) parameters (PR, QRS, QT, and QTc intervals).
+6 moreSecondary outcome measures
Cold Antibody Sub-Study: Changes in ECG parameters (PR, QRS, QT, and QTc intervals).
Cold Antibody Sub-Study: Incidence of AEs.
Cold Antibody Sub-Study: Incidence of clinically significant clinical laboratory abnormalities.
+18 moreOther outcome measures
Dose Escalation: Correlation of uptake of [111In]-FPI-1547 with biomarker results (e.g., immunohistochemistry (ICH) staining, [18F]-FDG Positron Emission Tomography (PET)).
Dose Escalation: Correlation of uptake of [111In]-FPI-1547 with observed toxicities following therapeutic administration of [225Ac]-FPI-1434 Injection.
Trial Design
4Treatment groups
Experimental Treatment
Group I: [225Ac]-FPI-1434 Single-Dose EscalationExperimental Treatment2 Interventions
Group II: [225Ac]-FPI-1434 Multi-Dose EscalationExperimental Treatment3 Interventions
[225Ac]-FPI-1434 treatment with or without pre-administration of FPI-1175 (cold antibody).
Group III: [225Ac]-FPI-1434 Multi-DoseExperimental Treatment3 Interventions
Phase 2 Tumour Cohort - Head & Neck Squamous Cell Carcinoma (HNSCC), Endometrial Cancer, Cervical Cancer, Ovarian Cancer, Triple Negative Breast Cancer (TNBC), HER2-negative, Adrenocortical Carcinoma (ACC), Uveal Melanoma, [225Ac]-FPI-1434 treatment with or without pre-administration of FPI-1175 (cold antibody).
Group IV: FPI-1175 Cold AntibodyExperimental Treatment3 Interventions
Find a Location
Who is running the clinical trial?
Fusion Pharmaceuticals Inc.Lead Sponsor
4 Previous Clinical Trials
273 Total Patients Enrolled
1 Trials studying Breast Cancer
6 Patients Enrolled for Breast Cancer
Julia Kazakin, MDStudy DirectorFusion Pharmaceuticals Inc.
1 Previous Clinical Trials
6 Total Patients Enrolled
1 Trials studying Breast Cancer
6 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My advanced cancer does not respond to standard treatments, or I cannot or choose not to receive them.I have received radiation treatment of more than 20 Gy to large bone marrow areas.I have been treated with nitrosoureas or actinomycin-D before.You have high levels of protein in your urine that could affect your health.My bone marrow is functioning well.I have had an organ or stem cell transplant.My cancer can be measured or evaluated by standard criteria.I am fully active or can carry out light work.My cancer is one of the specified types and is advanced, inoperable, or has returned.I do not have any severe illnesses that could interfere with the study.I have not had active treatment for another cancer, except for certain skin cancers or localized cancers, in the last 3 years.My scans show at least one tumor spot that the treatment can target.I can provide a sample of my tumor for testing.I haven't had cancer treatment or radiation in the last 14 days.I can lay flat and have no issues with undergoing imaging procedures.My heart, kidneys, and liver are functioning well.I do not have untreated brain metastasis needing steroids, surgery, or radiation.My cancer can be measured and hasn't responded to standard treatments.I haven't had radiopharmaceutical treatment in the last 6 months.I have side effects from past treatments, but not hair loss.I am not allergic to the trial drug or its components.
Research Study Groups:
This trial has the following groups:- Group 1: FPI-1175 Cold Antibody
- Group 2: [225Ac]-FPI-1434 Single-Dose Escalation
- Group 3: [225Ac]-FPI-1434 Multi-Dose Escalation
- Group 4: [225Ac]-FPI-1434 Multi-Dose
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.
Are there still openings available to volunteer for this clinical exploration?
"According to clinicaltrials.gov, this medical trial is actively recruiting patients at the present moment. The experiment was initially posted on January 17th 2019 and had its most recent update on October 27th 2022."
Answered by AI
What is the target size of enrollment for this clinical trial?
"Affirmative. Clinicaltrials.gov's records demonstrate that recruitment for this trial, which debuted on the 17th of January 2019, is ongoing at present. A total of 253 patients have to be recruited from 9 different medical centres."
Answered by AI
How widely dispersed are the sites of this research endeavor?
"This study is recruiting participants at the Masonic Cancer Center, University of Minnesota in Minneapolis, Juravinski Cancer Center - Hamilton Health in Hamilton, Ontario and Memorial Sloan Kettering Cancer Centre located in New york. Additionally, nine more sites are open to applicants."
Answered by AI
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