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Treatment for advanced prostate cancer using FPI-2265

A Phase 2/3, 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), Previously Treated With 177Lu-PSMA Radioligand Therapy (RLT)

Phase2; Phase3 Interventional Fusion Pharmaceuticals Inc. · NCT06402331

This study is testing a new treatment called FPI-2265 for adults with advanced prostate cancer who have already tried another therapy to see if it is safe and effective.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexMale
SponsorFusion Pharmaceuticals Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations18 sites (Duarte, California and 17 other locations)
Trial IDNCT06402331 on ClinicalTrials.gov

What this trial studies

This open-label, randomized, multicenter study evaluates the safety and tolerability of FPI-2265 (225Ac-PSMA-I&T) in adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously undergone treatment with lutetium-PSMA therapy. The study consists of two phases: Phase 2 focuses on dose optimization and determining the recommended regimen based on safety and anti-tumor activity, while Phase 3 will further assess efficacy. Participants will undergo PET/CT scans for eligibility and will be monitored for disease progression and adverse events throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adult males with PSMA-positive mCRPC who have previously been treated with lutetium-PSMA therapy.

Not a fit: Patients who have not undergone prior lutetium-PSMA therapy or those with non-PSMA-positive cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer who have limited treatment alternatives.

How similar studies have performed: Other studies using radioligand therapy for prostate cancer have shown promising results, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Phase 2: 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.
* 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.

Key Exclusion Criteria:

* Participants who received more than two prior lines of cytotoxic chemotherapy for CRPC.
* Phase 2: 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
* Participants with any liver metastases will be excluded from the Phase 2 segment of the study.
* 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.

Where this trial is running

Duarte, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Castration-resistant Prostate CancermCRPC225Ac-PSMA-I&TRadioligand therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.