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

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ClinicalTrials.gov Identifier: NCT05605522
Recruitment Status : Recruiting
First Posted : November 4, 2022
Last Update Posted : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
Fusion Pharmaceuticals Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma (PDAC) Squamous Cell Carcinoma of Head and Neck Colorectal Cancer Gastric Cancer Ewing Sarcoma NTSR1 Expressing Solid Tumours Neuroendocrine Differentiated (NED) Prostate Cancer Drug: [225]-FPI-2059 Drug: [111In]-FPI-2058 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours
Actual Study Start Date : February 7, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : September 2025


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.




Primary Outcome Measures :
  1. 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 ]
  2. Maximum tolerated dose (MTD) of [225Ac]-FPI-2059 [ Time Frame: 56 days post administration ]
  3. 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 ]

Secondary Outcome Measures :
  1. Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1 [ Time Frame: approximately 5 years post final administration ]
  2. Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar images [ Time Frame: within 56 days of administration ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05605522


Contacts
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Contact: Clinical Trials Fusion Pharmaceuticals 1 (888) 506-4215 clinicaltrials@fusionpharma.com

Locations
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United States, Alabama
University of Alabama at Birmingham Hospital Not yet recruiting
Birmingham, Alabama, United States, 35249
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
United States, Maryland
Advanced Molecular Imaging and Therapy Recruiting
Glen Burnie, Maryland, United States, 21061
United States, Nebraska
XCancer Omaha / Urology Cancer Center Recruiting
Omaha, Nebraska, United States, 68130
Contact: Luke Nordquist, Dr.    402-991-8468    Drnordquistguresearch@gucancer.com   
Contact: Tony Romero    (402) 697-2229    tromero@gucancer.com   
Australia, New South Wales
Westmead Hospital Recruiting
Sydney, New South Wales, Australia, 2145
Sponsors and Collaborators
Fusion Pharmaceuticals Inc.
Investigators
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Study Director: Joanne Schindler, MD, DVM Fusion Pharmaceuticals Inc.
Additional Information:
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Responsible Party: Fusion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT05605522    
Other Study ID Numbers: FPI-2059-101
First Posted: November 4, 2022    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fusion Pharmaceuticals Inc.:
Solid Tumor
FPI-2059
FPI-2058
Pancreas
Prostate
Neuroendocrine
Stomach cancer
Gastric
Ewing sarcoma
HNSCC
Squamous cell carcinoma
CRC
Colorectal
actinium
targeted alpha therapy
radiopharmaceuticals
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Sarcoma
Sarcoma, Ewing
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasms, Squamous Cell
Neoplasms, Connective and Soft Tissue
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Head and Neck Neoplasms