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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05363605
Registration number
NCT05363605
Ethics application status
Date submitted
26/04/2022
Date registered
6/05/2022
Date last updated
19/12/2023
Titles & IDs
Public title
A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours
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Scientific title
A Phase 1/2 Study of [225Ac]-FPI-1966, [111In]-FPI-1967, and Vofatamab in Participants With FGFR3-expressing Advanced, Inoperable, Metastatic and/or Recurrent Solid Tumours
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Secondary ID [1]
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FPI-1966-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
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Head and Neck Squamous Cell Carcinoma
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Bladder Carcinoma
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Susceptible FGFR3 Genetic Alterations
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FGFR3
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FGFR3 Overexpression
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FGFR3 Receptor
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FGFR3 Protein Overexpression
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Ovarian Cancer
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Colorectal Cancer
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Breast Cancer
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Liver Cancer
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Lung Cancer
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Gastric Cancer
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Cancer
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - [225Ac]-FPI-1966
Treatment: Drugs - [111In]-FPI-1967
Other interventions - vofatamab
Experimental: Phase 1 - Depending on assigned cohort, [In111]-FPI-1967/[225Ac]-FPI-1966 will be administered with or without pre-dosing with vofatamab.
Experimental: Phase 2 - 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.
Treatment: Drugs: [225Ac]-FPI-1966
[225Ac]-FPI-1966 is a targeted alpha therapeutic that consists of vofatamab, a bifunctional chelate, and actinium-225, an alpha particle emitting radionuclide. In Phase 1, the dose depends on cohort assignment. In Phase 2, the RP2D regimen will be administered.
Treatment: Drugs: [111In]-FPI-1967
[111In]-FPI-1967 is an imaging agent that consists of vofatamab, a bifunctional chelate and indium-111 radionuclide. Participants will receive [111In]-FPI-1967 Injection of 185 MBq for imaging.
Other interventions: vofatamab
Vofatamab is a Fibroblast Growth Factor Receptor 3 (FGFR3)-targeting human monoclonal antibody without a radioisotope. In Phase 1, the dose depends on cohort assignment. In Phase 2, if pre-dosing with vofatamab is indicated, the RP2D regimen will be administered.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1: Phase 1: Incidence of AEs to evaluate safety and tolerability of [225Ac]-FPI-1966, [111In]-FPI-1967, and vofatamab.
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Assessment method [1]
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Timepoint [1]
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Approximately 2 years post final administration
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Primary outcome [2]
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Phase 1: Maximum tolerated dose (MTD) of [225Ac]-FPI-1966
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Assessment method [2]
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Timepoint [2]
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Approximately 42 days post administration.
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Primary outcome [3]
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Phase 1: Radiation dose of [111In]-FPI-1967 and [225Ac]-FPI-1966 (whole body, organs, and selected regions of interest)
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Assessment method [3]
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Timepoint [3]
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Within one week of administration
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Primary outcome [4]
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Phase 1: Effect of pre-dose administration of vofatamab on the radiation dosimetry of [111In]-FPI-1967 and [225Ac]-FPI-1966.
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Assessment method [4]
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Timepoint [4]
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Within one week of administration
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Primary outcome [5]
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Phase 2: Objective response rate (ORR) (sum of complete and partial response) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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Assessment method [5]
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Timepoint [5]
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Up to two years post final administration.
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Secondary outcome [1]
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Phase 1 and 2: Anti-tumour activity of [225Ac]-FPI-1966 regimen measured by response per RECIST v1.1
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Assessment method [1]
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Timepoint [1]
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Approximately 2 years post final administration
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Secondary outcome [2]
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Phase 1 and 2: Tumour uptake of [111In]-FPI-1967 by evaluating SPECT/CT and/or planar images
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Assessment method [2]
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Timepoint [2]
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Within one week of administration
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Secondary outcome [3]
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Phase 2: Radiation dose of [111In]-FPI-1967 and [225Ac]-FPI-1966 (whole body, organs, and selected regions of interest)
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Assessment method [3]
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Timepoint [3]
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Within one week of administration
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Secondary outcome [4]
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Phase 1 and 2: Clearance for radioactivity and for the targeting antibody.
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Assessment method [4]
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Timepoint [4]
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28 days post final [225Ac]-FPI-1966administration
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Secondary outcome [5]
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Phase 1 and 2: Area under the curve (AUC) for radioactivity and targeting antibody
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Assessment method [5]
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Timepoint [5]
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28 days post final [225Ac]-FPI-1966administration.
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Secondary outcome [6]
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Phase 1 and 2: Maximum concentration after dosing (Cmax) for radioactivity and targeting antibody.
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Assessment method [6]
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Timepoint [6]
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28 days post final[225Ac]-FPI-1966 administration
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Secondary outcome [7]
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Phase 1 and 2: Half-life for radioactivity and targeting antibody.
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Assessment method [7]
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Timepoint [7]
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28 days post final [225Ac]-FPI-1966 administration
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Secondary outcome [8]
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Phase 1: Changes in clearance for radioactivity and targeting antibody following pre-dose administration of vofatamab
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Assessment method [8]
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Timepoint [8]
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28 days post final [225Ac]-FPI-1966 administration
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Secondary outcome [9]
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Phase 1: Changes in AUC for radioactivity and targeting antibody following pre-dose administration of vofatamab.
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Assessment method [9]
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Timepoint [9]
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28 days post final [225Ac]-FPI-1966 administration
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Secondary outcome [10]
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Phase 1: Changes in Cmax for radioactivity and targeting antibody following pre-dose administration of vofatamab.
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Assessment method [10]
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Timepoint [10]
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28 days post final [225Ac]-FPI-1966 administration
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Secondary outcome [11]
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Phase 1: Changes in half-life for radioactivity and targeting antibody following pre-dose administration of vofatamab
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Assessment method [11]
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Timepoint [11]
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28 days post final [225Ac]-FPI-1966 administration
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Eligibility
Key inclusion criteria
Key
- Signed ICF prior to initiation of any study-specific procedures
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically and/or cytologically documented diagnosis of locally advanced,
inoperable, or metastatic solid tumours
- Refractory to all standard treatments, or for whom standard treatment is not
available, or tolerable, or is contraindicated, or the participant refuses standard
therapy
- Measurable disease per RECIST v. 1.1
- Available tumour tissue (archival or fresh biopsy)
- Adequate bone marrow, heart, liver, and kidney function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior systemic radiopharmaceutical therapy within six months prior to the first dose
of [111In]-FPI-1967
- Prior radiation therapy (RT) to bone marrow > 20 Gy
- RT within 30 days prior to the first dose of [111In]-FPI-1967
- Prior anti-cancer treatment (chemotherapy, immunotherapy, hormonal therapy, targeted
therapy, or investigational agents) within a certain amount of time prior to
administration of the first dose of [111In]-FPI-1967
- Concurrent serious co-morbidities that could limit participants' full participation
and compliance
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/09/2023
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Sample size
Target
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Accrual to date
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Final
6
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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GC Murdoch - Murdoch
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Recruitment hospital [2]
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St Vincent's Hospital - Melbourne
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Recruitment postcode(s) [1]
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6150 - Murdoch
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Iowa
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Country [3]
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United States of America
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State/province [3]
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New York
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Fusion Pharmaceuticals Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This first-in-human study evaluates safety, tolerability and distribution of [225Ac]
FPI-1966, [111In]-FPI-1967, and vofatamab in patients with FGFR3-expressing solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05363605
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Julia Kazakin, MD
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Address
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Fusion Pharmaceuticals Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05363605
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