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Active, not recruitingNCT06909825Updated Oct 6, 2026

FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

A Phase 2 interventional study of FPI-2265 and Olaparib in Metastatic Castration-resistant Prostate Cancer, sponsored by Fusion Pharmaceuticals Inc.. Active, not recruiting at 4 sites in Australia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Fusion Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
85
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

This study is an open-label, multicenter study designed to investigate the efficacy, safety and tolerability of FPI-2265 (225Ac-PSMA-I\&T) in combination with Olaparib in participants with mCRPC. The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 and Olaparib in participants with metastatic castration-resistant prostate cancer.

Read the detailed description

This study is an open-label, multicenter study designed to investigate the efficacy, safety and tolerability of FPI-2265 (225Ac-PSMA-I\&T) in combination with Olaparib in participants with mCRPC. The study will be conducted in two parts, with Part A enrolling participants who have been previously treated with lutetium-177 (177Lu) vipivotide tetraxetan or other 177Lu-PSMA radioligand therapy (RLT) and Part B enrolling participants who have not been previously treated with lutetium-177 (177Lu) vipivotide tetraxetan or other 177Lu-PSMA radioligand therapy. For each part of the study, a Simon 2-stage design will be used to evaluate two dosing regimens. The purpose of this investigation is to determine the recommended FPI-2265 dose and regimen. Conclusions from this Phase 2 study will be based on safety, tolerability, and anti-tumor activity data. Participants with PSMA-positive mCRPC will be allocated to Arm 1 and Arm 2 in a singular, alternating fashion, until all Stage 1 participants are enrolled into each of the two regimens:

Arm 1: Will consist of up to six doses of FPI-2265 every six weeks at Dose A and olaparib twice a day on days 1 to 14 of each cycle.

Arm 2: Will consist of up to nine doses of FPI-2265 every four weeks at Dose B and olaparib twice a day on days 1 to 14 of each cycle Participants will be monitored and assessed for efficacy response, disease progression, and adverse events.

02

Conditions studied

  • Metastatic Castration-resistant Prostate Cancer

Keywords

  • mCRPC
  • 225Ac-PSMA-I&T
  • RLT
  • Radioligand Therapy
  • FPI-2265
  • Olaparib
  • Radioconjugate
03

In context

Lead sponsor

Fusion Pharmaceuticals Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
85 participants (estimated)

Study arms

  • 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)

    Drug: FPI-2265 · Drug: Olaparib

  • 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)

    Drug: FPI-2265 · Drug: Olaparib

Interventions

  • DrugFPI-2265

    PSMA ligand radiolabeled with Ac225

  • DrugOlaparib

    Poly (ADP-ribose) polymerase (PARP) inhibitor

06

What researchers measure

Primary outcomes

  1. Evaluate anti-tumour activity of FPI-2265 administered in combination with olaparib

    The frequency and proportion of participants with PSA50 response will be summarized, where PSA50 is defined as ≥50% decline in PSA level from pre-treatment.

    Time frame: From first dose until approximately 12 weeks after the first administered dose of FPI-2265

  2. Evaluate the safety and tolerability of FPI-2265 administered in combination with olaparib

    Safety will be assessed by percentage of patient with treatment emergent adverse events and serious adverse events; percentage of patients with SAEs during the first year of the long term follow up and the number of AESIs during the 5 year follow up period. Percentage of patients with interruption of FPI-2265; percentage of patients who discontinue treatment; number and grade for AEs related to study treatment.

    Time frame: From first dose until end of long-term follow-up, 5 years from the last administered dose of FPI-2265

07

Study locations

4 sites
  • Macquarie University Hospital
    Macquarie Park, New South Wales 2113, Australia
  • Princess Alexandra Hospital
    Woolloongabba, Queensland 4102, Australia
  • Icon Cancer Centre Kurralta Park
    Kurralta Park, South Australia 5037, Australia
  • Peter MacCallum Cancer Center
    Melbourne, Victoria 3000, Australia
08

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06909825
Lead sponsor
Fusion Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Apr 4, 2025
Start date
Feb 26, 2025
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Oct 6, 2026

Study contacts

Dipti Shoop
study director · Fusion Pharmaceuticals Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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