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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT06402331
Recruitment Status : Recruiting
First Posted : May 7, 2024
Last Update Posted : June 12, 2024
Information provided by (Responsible Party):
Fusion Pharmaceuticals Inc.

Brief Summary:
This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 in participants with PSMA-positive mCRPC who have been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy (RLT).

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Drug: FPI-2265 Phase 2 Phase 3

Detailed Description:

The purpose of the dose optimization segment (Phase 2) is to determine the recommended FPI-2265 dose and regimen. Conclusions from Phase 2 will be based on safety, tolerability, and anti-tumor activity.

Participants with PSMA positive scans will be randomized (1:1:1) to one of three different dosing arms:

Arm 1: Will consist of nine doses of FPI-2265, administered every four weeks at 50 kBq/kg.

Arm 2: Will consist of six doses of FPI-2265, administered every six weeks at 75 kBq/kg.

Arm 3: Will consist of four doses of FPI-2265, administered every eight weeks at 100 kBq/kg.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 5, 2024
Estimated Primary Completion Date : July 23, 2026
Estimated Study Completion Date : January 23, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: FPI-2265 50 kBq/kg
Arm 1: FPI-2265 administered by IV injection every four weeks; up to 9 doses.
Drug: FPI-2265
PSMA ligand radiolabeled with Ac225
Other Name: Ac225-PSMA I&T

Experimental: FPI-2265 75 kBq/kg
Arm 2: FPI-2265 administered by IV injection every six weeks; up to 6 doses.
Drug: FPI-2265
PSMA ligand radiolabeled with Ac225
Other Name: Ac225-PSMA I&T

Experimental: FPI-2265 100 kBq/kg
Arm 3: FPI-2265 administered by IV injection every eight weeks; up to 4 doses.
Drug: FPI-2265
PSMA ligand radiolabeled with Ac225
Other Name: Ac225-PSMA I&T

Primary Outcome Measures :
  1. 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 the last administered dose of FPI-2265. ]
    Frequencies and percentages of participants with TEAEs will be summarized. Analysis will also be completed regarding duration of TEAEs and their severity.

  2. Frequency and proportion of participants with PSA50 response [ Time Frame: From first dose until 12 weeks after the first administered dose of FPI-2265. ]
    PSA50 response is defined as a decline in PSA levels by at least 50% and is used to evaluate anti-tumor activity.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements.
  • 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.
  • 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 within two cycles 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT06402331

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Contact: Clinical Trials Fusion Pharmaceuticals Inc. 1 (888) 506-4215

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United States, California
VA Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Gholam Berenji, MD    310-268-3547   
Contact: Janake Wijesuriya    310-977-5209   
Principal Investigator: Gholam Berenji, MD         
United States, Michigan
BAMF Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Brandon Mancini, MD    616-330-3343   
Contact: Harshad Kulkarni, MD   
Principal Investigator: Brandon Mancini, MD         
United States, Nebraska
XCancer Recruiting
Omaha, Nebraska, United States, 68130
Contact: Luke Nordquist, MD    402-991-8468   
Contact: Tony Romero    402-697-2229   
Principal Investigator: Luke Nordquist, MD         
Sponsors and Collaborators
Fusion Pharmaceuticals Inc.
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Study Director: Keith Barnett Fusion Pharmaceuticals Inc.
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Responsible Party: Fusion Pharmaceuticals Inc. Identifier: NCT06402331    
Other Study ID Numbers: FPI-2265-202
First Posted: May 7, 2024    Key Record Dates
Last Update Posted: June 12, 2024
Last Verified: June 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fusion Pharmaceuticals Inc.:
Radioligand therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases