A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours
A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2145
- Westmead Hospital
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35249
- University of Alabama At Birmingham Hospital
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
Newport Beach, California, United States, 92663
- Hoag Family Cancer Institute
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University Of Kentucky
-
-
Maryland
-
Glen Burnie, Maryland, United States, 21061
- Advanced Molecular Imaging and Therapy
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University
-
-
Nebraska
-
Omaha, Nebraska, United States, 68130
- XCancer Omaha / Urology Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
|
[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.
[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
|
[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.
[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
Sponsor
Investigators
- Study Director: Aaron Enke, 3B Pharmaceuticals GmbH
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Neoplasms, Squamous Cell
- Neoplasms, Connective and Soft Tissue
- Osteosarcoma
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Squamous Cell Carcinoma of Head and Neck
- Carcinoma, Squamous Cell
- Sarcoma, Ewing
- Sarcoma
Other Study ID Numbers
- FPI-2059-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.