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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

— AlphaBreak  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06402331
• Other study ID #: FPI-2265-202
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 5, 2024
• Est. completion date: January 23, 2031

Study information

• Verified date: June 2024
• Source: Fusion Pharmaceuticals Inc.
• Contact: Clinical Trials Fusion Pharmaceuticals Inc.
• Phone: 1 (888) 506-4215
• Email: clinicaltrials[@]fusionpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 23, 2031
• Est. primary completion date: July 23, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 ???Tc 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.

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• FPI-2265
PSMA ligand radiolabeled with Ac225

Locations

Country	Name	City	State
United States	BAMF Health	Grand Rapids	Michigan
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California
United States	XCancer	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Fusion Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose until end of long-term follow-up, 5 years from the last administered dose of FPI-2265.
Primary	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.	From first dose until 12 weeks after the first administered dose of FPI-2265.