Trial Title:
A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours
NCT ID:
NCT05605522
Condition:
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
Conditions: Official terms:
Carcinoma, Squamous Cell
Sarcoma
Sarcoma, Ewing
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[225]-FPI-2059
Description:
[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.
Arm group label:
Phase 1 Dose Escalation
Arm group label:
Phase 1 Dose Expansion
Intervention type:
Drug
Intervention name:
[111In]-FPI-2058
Description:
[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.
Arm group label:
Phase 1 Dose Escalation
Arm group label:
Phase 1 Dose Expansion
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.
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham Hospital
Address:
City:
Birmingham
Zip:
35249
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Hoag Family Cancer Institute
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kentucky
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Facility:
Name:
Advanced Molecular Imaging and Therapy
Address:
City:
Glen Burnie
Zip:
21061
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
XCancer Omaha / Urology Cancer Center
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Luke Nordquist, Dr.
Phone:
402-991-8468
Email:
Drnordquistguresearch@gucancer.com
Contact backup:
Last name:
Tony Romero
Phone:
(402) 697-2229
Email:
tony@xcancer.com
Facility:
Name:
Westmead Hospital
Address:
City:
Sydney
Zip:
2145
Country:
Australia
Status:
Recruiting
Start date:
February 7, 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Fusion Pharmaceuticals Inc.
Agency class:
Industry
Source:
Fusion Pharmaceuticals Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05605522
http://fusionpharma.com/
