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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06909825




Registration number
NCT06909825
Ethics application status
Date submitted
21/03/2025
Date registered
4/04/2025
Date last updated
4/04/2025

Titles & IDs
Public title
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Scientific title
A Phase 2, Open-label, Multi-centre Study of FPI-2265 (225Ac-PSMA-I&T) and Olaparib in Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Secondary ID [1] 0 0
CT-2024-CTN-00137-1
Secondary ID [2] 0 0
FPI-2265-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FPI-2265
Treatment: Drugs - Olaparib

Experimental: Part A - Regimen 1: FPI-2265 (Dose A intravenously \[IV\] every six weeks) plus olaparib (twice daily \[BID\], on Days 1 to 14 of each cycle).

Regimen 2: . FPI-2265 (Dose B intravenously \[IV\] every 4 weeks) plus olaparib (twice daily \[BID\], on Days 1 to 14 of each cycle)

Experimental: Part B - Regimen 1: FPI-2265 (Dose A intravenously \[IV\] every six weeks) plus olaparib (g twice daily \[BID\], on Days 1 to 14 of each cycle).

Regimen 2: . FPI-2265 (Dose B intravenously \[IV\] every 4 weeks) plus olaparib (twice daily \[BID\], on Days 1 to 14 of each cycle)


Treatment: Drugs: FPI-2265
PSMA ligand radiolabeled with Ac225

Treatment: Drugs: Olaparib
Poly (ADP-ribose) polymerase (PARP) inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate anti-tumour activity of FPI-2265 administered in combination with olaparib
Timepoint [1] 0 0
From first dose until approximately 12 weeks after the first administered dose of FPI-2265
Primary outcome [2] 0 0
Evaluate the safety and tolerability of FPI-2265 administered in combination with olaparib
Timepoint [2] 0 0
From first dose until end of long-term follow-up, 5 years from the last administered dose of FPI-2265

Eligibility
Key inclusion criteria
1. Adult male participants with mCRPC that is progressing at the time of study entry
2. ECOG performance status 0-1 and life expectancy of at least three months
3. Must have received at least one novel anti-androgen deprivation therapy
4. Participants with known BRCA mutations should have received approved therapies such as PARP inhibitors, per Investigator discretion.
5. All prior treatment-related AEs must have resolved to CTCAE Grade =1 (except alopecia).
6. Participants must have had prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L)
7. Positive PSMA PET/CT scans .
8. Participants must have adequate organ and bone marrow function:

* Hgb >/= 9g/dL
* Platelets >/= 100 x 10^9/L
* ANC </= 1.5 x 10^9/L
* CrCL >/= 50 mL/min
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous treatment with any of the following within 6 months of first dose: Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation.
2. Participants who received more than two (2) prior lines of cytotoxic chemotherapy for CRPC.
3. Participants with known unresolved urinary tract obstruction.
4. Transfusion- or growth factor-dependent participants.
5. Participants with a history of CNS metastases are excluded, except those who have received therapy (and are neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity.
6. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
7. Participants with any liver metastases.
8. Participants with skeletal metastases presenting as a superscan .
9. Previous history of interstitial lung disease or non-infectious pneumonitis.
10. Participants with a history or clinical and/or laboratory features suggestive of MDS/AML.
11. Major surgery =28 days prior to the first dose of study treatment.
12. Planning to conceive a pregnancy during the treatment and up to six months after the last treatment.
13. Participants unable to swallow orally administered medications or with malabsorptive gastrointestinal disorders.
14. Concomitant use of known strong or moderate CYP3A inhibitors or inducers

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
Parallel
Other design features
Phase
Phase 2
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
26/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/08/2030
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [3] 0 0
Icon Cancer Centre North Lakes - North Lakes
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Icon Cancer Centre Kurralta Park - Kurralta Park
Recruitment hospital [7] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [3] 0 0
4509 - North Lakes
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3000 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Keith Barnett
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, Inc. Sponsor
Address 0 0
Country 0 0
Phone 0 0
1(888) 506-4215
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06909825