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

April 4, 2024 updated by: Fusion Pharmaceuticals Inc.

A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University of Alabama At Birmingham Hospital
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Family Cancer Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Advanced Molecular Imaging and Therapy
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key 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)

Key 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

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 Dose Escalation
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.

Drug: [111In]-FPI-2058
[111In]-FPI-2058 is an imaging agent that consists of an NTSR1-targeting small molecule linked to In-111.Participants will receive [111In]-FPI-2058 by IV Injection for imaging once during screening period. The dose is consistent across cohorts.
Experimental: Phase 1 Dose Expansion
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.

Drug: [111In]-FPI-2058
[111In]-FPI-2058 is an imaging agent that consists of an NTSR1-targeting small molecule linked to In-111.Participants will receive [111In]-FPI-2058 by IV Injection for imaging once during screening period. The dose is consistent across cohorts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058
Time Frame: approximately 5 years post final administration
approximately 5 years post final administration
Maximum tolerated dose (MTD) of [225Ac]-FPI-2059
Time Frame: 56 days post administration
56 days post administration
Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest
Time Frame: within 56 days of administration
within 56 days of administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1
Time Frame: approximately 5 years post final administration
approximately 5 years post final administration
Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar images
Time Frame: within 56 days of administration
within 56 days of administration
Pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2059 by measuring changes in clearance, AUC, Cmax, and half-life
Time Frame: approximately 36 days of final administration
approximately 36 days of final administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fusion Pharmaceuticals Inc.

Investigators

  • Study Director: Joanne Schindler, MD, DVM, Fusion Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPI-2059-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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