Metastatic Castration-resistant Prostate CancerPhase 2NCT06909825
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 2 study testing FPI-2265 and Olaparib in people with Metastatic Castration-resistant Prostate Cancer, run by Fusion Pharmaceuticals Inc. at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- FPI-2265 and Olaparib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 4 sitesAustralia
- Study dates
- 26 Feb 2025to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male participants with mCRPC that is progressing at the time of study entry
- ECOG performance status 0-1 and life expectancy of at least three months
- Must have received at least one novel anti-androgen deprivation therapy
- Participants with known BRCA mutations should have received approved therapies such as PARP inhibitors, per Investigator discretion.
- All prior treatment-related AEs must have resolved to CTCAE Grade ≤1 (except alopecia).
- 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)
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- Positive PSMA PET/CT scans .
- 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
Who cannot join
- Previous treatment with any of the following within 6 months of first dose: Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation.
- Participants who received more than two (2) prior lines of cytotoxic chemotherapy for CRPC.
- Participants with known unresolved urinary tract obstruction.
- Transfusion- or growth factor-dependent participants.
- 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.
- Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
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- Participants with any liver metastases.
- Participants with skeletal metastases presenting as a superscan .
- Previous history of interstitial lung disease or non-infectious pneumonitis.
- Participants with a history or clinical and/or laboratory features suggestive of MDS/AML.
- Major surgery ≤28 days prior to the first dose of study treatment.
- Planning to conceive a pregnancy during the treatment and up to six months after the last treatment.
- Participants unable to swallow orally administered medications or with malabsorptive gastrointestinal disorders.
- Concomitant use of known strong or moderate CYP3A inhibitors or inducers
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, 5037
Macquarie University Hospital
Macquarie Park, New South Wales, 2113
Peter MacCallum Cancer Center
Melbourne, Victoria, 3000
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
Official 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)
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.
- Being tested
- FPI-2265, Olaparib
- Keywords
- mCRPC, 225Ac-PSMA-I&T, RLT, Radioligand Therapy, FPI-2265, Olaparib, Radioconjugate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPI-2265Drug
PSMA ligand radiolabeled with Ac225
OlaparibDrug
Poly (ADP-ribose) polymerase (PARP) inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | 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) Receives: Drug: FPI-2265; Drug: Olaparib |
| Part B | Experimental | 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) Receives: Drug: FPI-2265; Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose until approximately 12 weeks after the first administered dose of FPI-2265
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.
Measured: From first dose until end of long-term follow-up, 5 years from the last administered dose of FPI-2265
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start26 Feb 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fusion Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dipti Shoop, Study director, Fusion Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909825
- Sponsor's protocol ID
- FPI-2265-203
- Other IDs
- CT-2024-CTN-00137-1
- Status last verified
- Nov 2026
- First submitted
- 21 Mar 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06909825
- Acronym / sponsor ID
- FPI-2265-203
- Keywords
- mCRPC, 225Ac-PSMA-I&T, RLT, Radioligand Therapy, FPI-2265, Olaparib, Radioconjugate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Fusion Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: FPI-2265, Drug: OlaparibRegimen 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) |
| Part B | Experimental | Drug: FPI-2265, Drug: OlaparibRegimen 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult male participants with mCRPC that is progressing at the time of study entry
- ECOG performance status 0-1 and life expectancy of at least three months
- Must have received at least one novel anti-androgen deprivation therapy
- Participants with known BRCA mutations should have received approved therapies such as PARP inhibitors, per Investigator discretion.
- All prior treatment-related AEs must have resolved to CTCAE Grade ≤1 (except alopecia).
Key exclusion criteria (14 listed)
- Previous treatment with any of the following within 6 months of first dose: Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation.
- Participants who received more than two (2) prior lines of cytotoxic chemotherapy for CRPC.
- Participants with known unresolved urinary tract obstruction.
- Transfusion- or growth factor-dependent participants.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FPI-2265PSMA ligand radiolabeled with Ac225 | Drug | Part A, Part B |
| OlaparibPoly (ADP-ribose) polymerase (PARP) inhibitor | Drug | Part A, Part B |
Primary outcome
Evaluate anti-tumour activity of FPI-2265 administered in combination with olaparib
Time frame: From first dose until approximately 12 weeks after the first administered dose of FPI-2265
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.
Evaluate the safety and tolerability of FPI-2265 administered in combination with olaparib
Time frame: From first dose until end of long-term follow-up, 5 years from the last administered dose of FPI-2265
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dipti Shoop study director
Fusion Pharmaceuticals Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FPI-2265 and Olaparib in people with Metastatic Castration-resistant Prostate Cancer, run by Fusion Pharmaceuticals Inc. at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate anti-tumour activity of FPI-2265 administered in combination with olaparib (time frame: From first dose until approximately 12 weeks after the first administered dose of FPI-2265). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.