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)
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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). The purpose of the study is to determine the safety and tolerability, and recommended dose and regiment of FPI-2265.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
City of Hope Comprehensive Cancer Center
RECRUITING
Duarte
Hoag Health Center Irvine
RECRUITING
Irvine
University of California Los Angeles
RECRUITING
Los Angeles
VA Greater Los Angeles Healthcare System
RECRUITING
Los Angeles
UCSF School of Medicine
RECRUITING
San Francisco
Florida
Biogenix Molecular, LLC
RECRUITING
Miami
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Maryland
United Theranostics
ACTIVE_NOT_RECRUITING
Glen Burnie
Michigan
BAMF Health
RECRUITING
Grand Rapids
Missouri
SSM Health Saint Louis University Hospital
RECRUITING
St Louis
Nebraska
XCancer
RECRUITING
Omaha
New Mexico
New Mexico Oncology Hematology Consultants Ltd.
RECRUITING
Albuquerque
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Memorial Sloan Kettering Cancer Center - NYC
RECRUITING
New York
Oregon
Oregon Health and Science University (OHSU, Knight Cancer Center)
RECRUITING
Portland
Texas
The University of Texas Southwestern Medical Center
RECRUITING
Dallas
VA North Texas Health Care System, Nuclear Medicine Service