A Study Of [225Ac]-FPI-2059 In Adult Participants With Solid Tumours

Study Overview

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

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.

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

FPI-2059-101

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-10-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-24
First Submitted that Met QC Criteria 2022-10-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-01-28
First Posted (ACTUAL) 2022-11-04	Results First Posted N/A	Last Verified 2024-04

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

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. Th 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. Th 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.

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. Th

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. Th

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

Secondary Outcome Measures	Measure Description	Time Frame
Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1		approximately 5 years post final administration
Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar images		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		approximately 36 days of final administration

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Joanne Schindler, MD, DVM, Fusion Pharmaceuticals Inc.

Publications

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

General Publications

No publications available

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Clinical Trial Record