vofatamab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Iowa Hospitals and Clinics, Iowa City, IA
Breast Cancer+19 More
vofatamab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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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. The medication vofatamab is being used to treat Breast Cancer in this trial, and has been previously approved by the FDA to treat a different condition. All patients in the trial will be receiving the medication, as there is no placebo group. The treatment is free for patients.

Eligible Conditions

  • Breast Cancer
  • Malignant Neoplasms
  • Urinary Bladder
  • Solid Tumors, Advanced Solid Tumors
  • FGFR3 Receptor
  • Ovarian Cancer
  • Susceptible FGFR3 Genetic Alterations
  • Colorectal Carcinoma
  • Lung Cancers
  • Liver Cancer
  • FGFR3
  • FGFR3 Overexpression
  • Malignant Neoplasm of Stomach
  • Fingerprints, Peptide

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

10 Primary · 22 Secondary · Reporting Duration: Up to two years post final [225Ac]-FPI-1966 administration.

Day 28
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.
Phase 1 and 2: Half-life for radioactivity and targeting antibody.
Phase 1 and 2: Maximum concentration after dosing (Cmax) for radioactivity and targeting antibody.
Phase 1: Changes in AUC for radioactivity and targeting antibody following pre-dose administration of vofatamab.
Phase 1: Changes in Cmax for radioactivity and targeting antibody following pre-dose administration of vofatamab.
Phase 1: Changes in clearance for radioactivity and targeting antibody following pre-dose administration of vofatamab.
Phase 1: Changes in half-life for radioactivity and targeting antibody following pre-dose administration of vofatamab.
Day 42
Phase 1: Incidence of dose limiting toxicities (DLTs).
Day 28
Phase 1: Changes in electrocardiogram (ECG) parameters (PR, QRS, QT, and QTcF intervals) compared to baseline.
Phase 2: Changes in electrocardiogram (ECG) parameters (PR, QRS, QT, and QTcF intervals) compared to baseline.
Approximately 28 post final [225Ac]-FPI-1966 administration.
Phase 1: Incidence of clinically significant clinical laboratory abnormalities compared to baseline.
Phase 2: Incidence of clinically significant clinical laboratory abnormalities compared to baseline.
Approximately two years post final [225Ac]-FPI-1966 administration.
Phase 1: Incidence of Adverse Events (AEs)
Phase 2: Incidence of Adverse Events (AEs)
Up to two years post final [225Ac]-FPI-1966 administration.
Phase 1 and 2: Disease control rate (DCR).
Phase 1 and 2: Duration of response (DoR).
Phase 1 and 2: Overall survival (OS).
Phase 1 and 2: Progression free survival (PFS).
Phase 1 and 2: Time to progression (TTP).
Phase 1 and 2: Time to response (TTR).
Phase 1: ORR (sum of complete and partial response) per Positron Emission Tomography Response Criteria (PERCIST) v1.0.
Phase 1: ORR (sum of complete and partial response) per RECIST v1.1.
Phase 2: Objective response rate (ORR) (sum of complete and partial response) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Within one week of the [111In]-FPI-1967 administration.
Phase 1 and 2: Tumor uptake of [111In]-FPI-1967 Injection in selected regions of interest on SPECT/CT images and/or planar images.
Phase 1: Changes in radiation doses for selected organs and whole body both for [111In]-FPI-1967 and [225Ac]-FPI-1966 following pre-dose administration of vofatamab.
Phase 1: Changes in radiation doses for tumors for [111In]-FPI-1967 and [225Ac]-FPI-1966 following pre-dose administration of vofatamab.
Phase 1: Changes in tumor uptake of [111In]-FPI-1967 Injection in selected regions of interest on SPECT/CT and/or planar images following pre-dose administration of vofatamab.
Phase 1: Radiation doses for selected organs and whole body both for [111In]-FPI-1967 and [225Ac]-FPI-1966.
Phase 1: Radiation doses for tumors for both for [111In]-FPI-1967 and [225Ac]-FPI-1966.
Phase 2: Radiation doses for selected organs and whole body both for [111In]-FPI-1967 and [225Ac]-FPI-1966.
Phase 2: Radiation doses for tumors for both for [111In]-FPI-1967 and [225Ac]-FPI-1966.

Trial Safety

Safety Progress

1 of 3

Other trials for Breast Cancer

Trial Design

2 Treatment Groups

Phase 2
1 of 2
Phase 1
1 of 2
Experimental Treatment

155 Total Participants · 2 Treatment Groups

Primary Treatment: vofatamab · No Placebo Group · Phase 1 & 2

Phase 2Experimental Group · 3 Interventions: [111In]-FPI-1967, [225Ac]-FPI-1966, vofatamab · Intervention Types: Drug, Drug, Biological
Phase 1Experimental Group · 3 Interventions: [111In]-FPI-1967, [225Ac]-FPI-1966, vofatamab · Intervention Types: Drug, Drug, Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to two years post final [225ac]-fpi-1966 administration.
Closest Location: University of Iowa Hospitals and Clinics · Iowa City, IA
Photo of Iowa City 1Photo of Iowa City 2Photo of Iowa City 3
2006First Recorded Clinical Trial
12 TrialsResearching Breast Cancer
399 CompletedClinical Trials

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between 18 and 49 years of age, and you are either male or female.
You have histologically and/or cytologically documented locally advanced, inoperable, or metastatic solid tumours.
You have measurable disease per RECIST v
You have adequate bone marrow, cardiovascular, hepatic, and renal function.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.