Share

Save

A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours

PHASE1RECRUITING

This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of \[225Ac\]-FPI-2059 and \[111In\]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.

info
Simpliy with AI

Study details:

This is a first-in-human, Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2059 and \[111In\]-FPI-2058, as well as the pharmacodynamics and preliminary anti-tumour activity of \[225Ac\]-FPI-2059 in participants with neurotensin receptor 1 (NTSR1)-expressing advanced, metastatic and/or recurrent solid tumours. The study will employ a 3+3 dose escalation design to identify the recommended phase 2 dose (RP2D) and regimen of \[225Ac\]-FPI-2059 administered intravenously every 56 days. After the RP2D for \[225Ac\]-FPI-2059 is determined, enrolment will continue into an expansion cohort, to confirm the safety and tolerability of the RP2D, as well as to identify any preliminary evidence of efficacy in selected NTSR1-expressing tumour types.

info
Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Signed ICF prior to initiation of any study-specific procedures
  • Histologically and/or cytologically confirmed solid tumor that is metastatic or locally advanced, inoperable, or recurrent. Solid tumors indications may include PDAC, CRC, NED prostate cancer, gastric cancer, SCCHN, and Ewing sarcoma.
  • Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the patient refuses standard therapy
  • Measurable disease per RECIST v.1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Sufficient target expression in at least one measurable lesion as determined by imaging following injection of [111In]-FPI-2058
  • Adequate organ function
  • Tumor tissue (either archival within the last 24 months or fresh biopsy)

    • Exclusion criteria

  • Previous treatment with any radiopharmaceutical
  • Contraindications to or inability to perform the imaging procedures required in this study
  • Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within certain amount of time prior to administration of the first dose of [111In]-FPI-2058
  • Radiation therapy (RT) within 28 days prior to the first dose of [111In]-FPI-2058
  • Patients with known CNS metastatic disease
  • Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements
  • Known or suspected allergies or contraindication to the investigational treatment
  • Received any type of vaccine within 30 days prior to the first dose of [111In]-FPI-2058
    • info
    Simplify with AI

    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-02-07

    Primary completion: 2025-06-01

    Study completion finish: 2025-09-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT05605522

    Intervention or treatment

    DRUG: [225]-FPI-2059

    DRUG: [111In]-FPI-2058

    Conditions

    • • Squamous Cell Carcinoma of Head and Neck
    • • Colorectal Cancer
    • • Gastric Cancer
    • • Pancreatic Ductal Adenocarcinoma (PDAC)
    • • Ewing Sarcoma
    • • NTSR1 Expressing Solid Tumours
    • • Neuroendocrine Differentiated (NED) Prostate Cancer
    Image related to Squamous Cell Carcinoma of Head and Neck

    • Condition: Squamous Cell Carcinoma of Head and Neck, Colorectal Cancer and more

    • DRUG: [225]-FPI-2059 and other drugs

    • Sydney, New South Wales, Australia

    • Sponsor: Fusion Pharmaceuticals Inc.

    You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

    Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

    Find a site

    Closest Location:

    Westmead Hospital

    Research sites nearby

    Select from list below to view details:

    • Westmead Hospital

      Sydney, New South Wales, Australia

    Loading...

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Phase 1 Dose Escalation
    • Not Specified
    DRUG: [225]-FPI-2059
    • \[225Ac\]-FPI-2059 is a targeted alpha therapeutic that consists of an NTSR1-targeting small molecule that is linked to Ac-225, an alpha particle emitting radionuclide. Participants will be dosed through IV administration every 56 days up to four cycles. The dose depends on cohort assignment.
    • In the Dose Expansion arm, \[225Ac\]-FPI-2059 will be administered at the RP2D as determined in Phase 1 Dose Escalation.
    EXPERIMENTAL: Phase 1 Dose Expansion
    • Not Specified
    DRUG: [225]-FPI-2059
    • \[225Ac\]-FPI-2059 is a targeted alpha therapeutic that consists of an NTSR1-targeting small molecule that is linked to Ac-225, an alpha particle emitting radionuclide. Participants will be dosed through IV administration every 56 days up to four cycles. The dose depends on cohort assignment.
    • In the Dose Expansion arm, \[225Ac\]-FPI-2059 will be administered at the RP2D as determined in Phase 1 Dose Escalation.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058Not Specifiedapproximately 5 years post final administration
    Maximum tolerated dose (MTD) of [225Ac]-FPI-2059Not Specified56 days post administration
    Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interestNot Specifiedwithin 56 days of administration

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1Not Specifiedapproximately 5 years post final administration
    Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar imagesNot Specifiedwithin 56 days of administration
    Pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2059 by measuring changes in clearance, AUC, Cmax, and half-lifeNot Specifiedapproximately 36 days of final administration

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

    No questions submitted. Be the first to ask a question!

    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

    Clinical Trials Gov: A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours

    Other trails to consider

    Top searched conditions

    ABN: 29 640 485 105 © 2025 Clinrol