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Radioisotope Therapy

vofatamab for Bladder Cancer

Phase 1 & 2
Waitlist Available
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 2 years post final administration
Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see if it is safe and effective. It is open to people with advanced cancer that has spread or come back and express the FGFR3 protein. The trial will happen in two phases. The first phase will test different doses of the treatment to see what is safe. The second phase will test if the treatment works against different types of tumors.

Eligible Conditions
  • Fibroblast Growth Factor Receptor 3 Genetic Alterations
  • Bladder Cancer
  • Ovarian Cancer
  • Fibroblast Growth Factor Receptor 3
  • Colorectal Cancer
  • No disease or condition mentioned.
  • Liver Cancer
  • Fibroblast Growth Factor Receptor 3 Overexpression
  • Breast Cancer
  • Lung Cancer
  • Stomach Cancer
  • Solid Tumors
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years post final administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years post final administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic radiology procedure
Phase 1: Maximum tolerated dose (MTD) of [225Ac]-FPI-1966
Phase 1: Phase 1: Incidence of AEs to evaluate safety and tolerability of [225Ac]-FPI-1966, [111In]-FPI-1967, and vofatamab.
+2 more
Secondary outcome measures
Phase 1 and 2: Anti-tumour activity of [225Ac]-FPI-1966 regimen measured by response per RECIST v1.1
Phase 1 and 2: Area under the curve (AUC) for radioactivity and targeting antibody
Phase 1 and 2: Clearance for radioactivity and for the targeting antibody.
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment3 Interventions
Depending on assigned cohort, [In111]-FPI-1967/[225Ac]-FPI-1966 will be administered either with or without pre-administration of vofatamab, depending on the RP2D/regimen as determined in the phase 1 portion of the study.
Group II: Phase 1Experimental Treatment3 Interventions
Depending on assigned cohort, [In111]-FPI-1967/[225Ac]-FPI-1966 will be administered with or without pre-dosing with vofatamab.

Find a Location

Who is running the clinical trial?

Fusion Pharmaceuticals Inc.Lead Sponsor
4 Previous Clinical Trials
520 Total Patients Enrolled
Julia Kazakin, MDStudy DirectorFusion Pharmaceuticals Inc.
1 Previous Clinical Trials
253 Total Patients Enrolled

Media Library

[225Ac]-FPI-1966 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05363605 — Phase 1 & 2
[225Ac]-FPI-1966 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05363605 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings in this clinical trial for new patients?

"That is correct, the trial detailed on clinicaltrials.gov is presently looking for individuals to participate. This particular study was first advertised on April 20th, 2022 and received its most recent update on October 25th, 2022. In total, 155 patients are needed from 3 separate locations."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
City of Hope
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours
2022. "A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05363605.
~2 spots leftby May 2025
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