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Metastatic Castration-resistant Prostate CancerPhase 2AlphaBreakNCT06402331

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

A Phase 2 study testing FPI-2265 in people with Metastatic Castration-resistant Prostate Cancer, run by Fusion Pharmaceuticals Inc. at 18 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I\&T). Patient population is adult participants with PSMA positive mCRPC who have had previous treatment with with 177Lu-PSMA-617 or another 177Lu-PSMA radioconjugate (RC). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
FPI-2265
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
18 sitesUnited States
Study dates
5 Mar 2024to 23 Jan 2031
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

  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Diagnosis of adenocarcinoma of prostate proven by histopathology.
  • Must have had prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone
  • Progressive mCRPC at time of study entry.
  • Must have been previously treated with lutetium-PSMA therapy (lutetium-177 vipivotide tetraxetan or other lutetium-177-PSMA RLT). Treatment must have been completed >6 weeks prior to the first dose of study drug.
  • Participants with known BRCA mutations should have received FDA-approved therapies such as PARP inhibitors, per Investigator discretion.
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  • Positive PSMA PET/CT scan
  • Adequate organ function
  • For participants who have partners of childbearing potential: Partner and/or participant must not be planning to conceive and must use a method of birth control with adequate barrier protection deemed acceptable by the Principal Investigator during the study treatment and for six months after last study drug administration.

Who cannot join

  • Participants who received more than two prior lines of cytotoxic chemotherapy for CRPC.
  • Participants who progress prior to administration of the 3rd cycle of prior treatment with 177Lu-PSMA therapy
  • All prior treatment-related adverse events must have resolved to Grade ≤1 (CTCAE v5.0). Alopecia and stable persistent Grade 2 peripheral neuropathy may be allowed at the discretion of the Investigator.
  • Participants with known, unresolved, urinary tract obstruction are excluded.
  • Administration of any systemic cytotoxic or investigational therapy ≤30 days of the first dose of study treatment or five half-lives, whichever is shorter. Completion of large-field external beam radiotherapy ≤four weeks of the first dose of study treatment.
  • Participants with a history of central nervous system (CNS) metastases are excluded except those who have received therapy
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  • Participants with any liver metastases will be excluded
  • Participants with skeletal metastases presented as a superscan on a ⁹⁹ᵐTc bone scan.
  • Previous or concurrent cancer that is distinct from the cancer under investigation in primary site or histology, except treated cutaneous basal cell carcinoma or squamous cell carcinoma and superficial bladder tumors. Any cancer curatively treated >two years prior to the first dose of treatment is permitted.
  • Concurrent serious (as determined by the investigator) medical conditions
  • Major surgery ≤30 days prior to the first dose of study treatment.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • New Mexico Oncology Hematology Consultants Ltd.

    Albuquerque, New Mexico, 87109

  • VA North Texas Health Care System, Nuclear Medicine Service

    Dallas, Texas, 75216

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • United Theranostics

    Glen Burnie, Maryland, 21061

  • BAMF Health

    Grand Rapids, Michigan, 49503

  • U.T. MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Hoag Health Center Irvine

    Irvine, California, 92618

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Biogenix Molecular, LLC

    Miami, Florida, 33165

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center - NYC

    New York, New York, 10065

  • XCancer

    Omaha, Nebraska, 68130

  • Oregon Health and Science University (OHSU, Knight Cancer Center)

    Portland, Oregon, 97239-3098

  • UCSF School of Medicine

    San Francisco, California, 94143

  • SSM Health Saint Louis University Hospital

    St Louis, Missouri, 63104

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of FPI-2265 (225Ac-PSMA-I&T) in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I\&T). Patient population is adult participants with PSMA positive mCRPC who have had previous treatment with with 177Lu-PSMA-617 or another 177Lu-PSMA radioconjugate (RC). The purpose of the study is to determine the safety and tolerability, and recommended dose and regiment of FPI-2265.

Read the detailed description

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I\&T). The purpose of this dose optimization study is to determine the recommended FPI-2265 dose and regimen. Conclusions will be based on safety, tolerability, and anti-tumor activity.

Screening Period: At screening, participants will be assessed for eligibility and undergo a positron emission tomography (PET)/computed tomography (CT) scan to evaluate PSMA positivity. Only participants with PSMA positive cancer and confirmed eligibility criteria will be randomized.

Participants randomized will enter the treatment period and receive investigational doses of FPI2265 according to the dose level and schedule as specified per proposed dose arm.

Part A participants will enroll 1:1:1 at three dose level/schedules, to arms 1, 2 or 3

Part B participants will enroll after completion of part A, in a 1:1 randomization scheme to arms 6 or 7.

Once Part A is fully enrolled and participants have been followed for at least 12 weeks, data from Arm 1 and 2 will be analyzed to assess the feasibility of enrolling participants to arms 4 and 5.

All participants will be monitored and assessed for efficacy response, disease progression and adverse events.

Supportive care will be allowed in all arms at the discretion of the investigator and includes available care for the eligible participant according to best institutional practice for mCRPC treatment, including androgen deprivation therapy (ADT).

Follow-up after end of treatment visit will proceed for 5 years.

5 participants will be enrolled into a dosimetry substudy (open at select sites only). Dosimetry substudy participants will be administered one dose at of FPI2265 and proceed with dosimetric assessments will be taken at a number of timepoints after dose administration.

Being tested
FPI-2265
Keywords
mCRPC, 225Ac-PSMA-I&T, Radioligand therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FPI-2265Drug

    Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac.

    Other Names:

    225Ac-PSMA-I\&T

Study groups in NCT06402331
Study groupRoleWhat they receive
Part A Arm 1ExperimentalNot described
Receives: Drug: FPI-2265
Part A Arm 2ExperimentalNot described
Receives: Drug: FPI-2265
Part A Arm 3ExperimentalNot described
Receives: Drug: FPI-2265
Part B Arm 4Experimentalto be utilized based on analysis of Part A
Receives: Drug: FPI-2265
Part B Arm 5Experimentalto be utilized based on analysis of Part A
Receives: Drug: FPI-2265
Part B Arm 6ExperimentalNot described
Receives: Drug: FPI-2265
Part B Arm 7ExperimentalNot described
Receives: Drug: FPI-2265

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency, duration, and severity of treatment-emergent adverse events (TEAEs)

    Frequencies and percentages of participants with TEAEs will be summarized. Analysis will also be completed regarding duration of TEAEs and their severity.

    Measured: From first dose until end of long-term follow-up, 5 years from end of treatment visit.

  2. Frequency and proportion of participants with PSA50 response

    PSA50 response is defined as a decline in PSA levels by at least 50% and is used to evaluate anti-tumor activity.

    Measured: From first dose until 12 weeks after the first 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.

  1. First posted7 May 2024
  2. Study start5 Mar 2024
  3. Primary completion23 Dec 2026 (estimated)
  4. Study completion23 Jan 2031 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06402331
Sponsor's protocol ID
FPI-2265-202
Acronym
AlphaBreak
Status last verified
Apr 2026
First submitted
26 Apr 2024
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FPI-2265 in people with Metastatic Castration-resistant Prostate Cancer, run by Fusion Pharmaceuticals Inc. at 18 sites in United States.

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 9 inclusion and 11 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. 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?

Frequency, duration, and severity of treatment-emergent adverse events (TEAEs) (time frame: From first dose until end of long-term follow-up, 5 years from end of treatment visit.). 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?

On the ClinicalTrials.gov record for NCT06402331.

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 8 Apr 2026.

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