Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05605522




Registration number
NCT05605522
Ethics application status
Date submitted
31/10/2022
Date registered
4/11/2022
Date last updated
5/04/2024

Titles & IDs
Public title
A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours
Scientific title
A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours
Secondary ID [1] 0 0
FPI-2059-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Ductal Adenocarcinoma (PDAC) 0 0
Squamous Cell Carcinoma of Head and Neck 0 0
Colorectal Cancer 0 0
Gastric Cancer 0 0
Ewing Sarcoma 0 0
NTSR1 Expressing Solid Tumours 0 0
Neuroendocrine Differentiated (NED) Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - [225]-FPI-2059
Treatment: Drugs - [111In]-FPI-2058

Experimental: Phase 1 Dose Escalation -

Experimental: Phase 1 Dose Expansion -


Treatment: Drugs: [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.

Treatment: Drugs: [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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058
Timepoint [1] 0 0
approximately 5 years post final administration
Primary outcome [2] 0 0
Maximum tolerated dose (MTD) of [225Ac]-FPI-2059
Timepoint [2] 0 0
56 days post administration
Primary outcome [3] 0 0
Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest
Timepoint [3] 0 0
within 56 days of administration
Secondary outcome [1] 0 0
Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1
Timepoint [1] 0 0
approximately 5 years post final administration
Secondary outcome [2] 0 0
Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar images
Timepoint [2] 0 0
within 56 days of administration
Secondary outcome [3] 0 0
Pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2059 by measuring changes in clearance, AUC, Cmax, and half-life
Timepoint [3] 0 0
approximately 36 days of final administration

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fusion Pharmaceuticals Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05605522
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joanne Schindler, MD, DVM
Address 0 0
Fusion Pharmaceuticals Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Fusion Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1 (888) 506-4215
Fax 0 0
Email 0 0
clinicaltrials@fusionpharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05605522