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NCT06402331 | RECRUITING | Metastatic Castration-resistant Prostate Cancer

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

Fusion Pharmaceuticals Inc.

Brief 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.

Condition or disease

Metastatic Castration-resistant Prostate Cancer

Intervention/treatment

FPI-2265

Phase

PHASE2

PHASE3

Detailed Description:

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I\&T). 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. 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 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
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 : 2024-03-05
Estimated Primary Completion Date : 2026-07-23
Estimated Study Completion Date : 2031-01-23

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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.
FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Location Details

NCT06402331

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

RECRUITING

United States, California

Hoag Health Center Irvine

Irvine, California, United States, 92618

RECRUITING

United States, California

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States, 90073

RECRUITING

United States, California

University of California Los Angeles

Los Angeles, California, United States, 90095

RECRUITING

United States, California

UCSF School of Medicine

San Francisco, California, United States, 94143

RECRUITING

United States, Florida

Biogenix Molecular, LLC

Miami, Florida, United States, 33165

RECRUITING

United States, Iowa

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Maryland

United Theranostics

Glen Burnie, Maryland, United States, 21061

RECRUITING

United States, Road cancer

BAMF Health

Grand Rapids, Road cancer, United States, 49503

RECRUITING

United States, Missouri

SSM Health Saint Louis University Hospital

Saint Louis, Missouri, United States, 63104

RECRUITING

United States, Nebraska

XCancer

Omaha, Nebraska, United States, 68130

RECRUITING

United States, New Mexico

New Mexico Oncology Hematology Consultants Ltd.

Albuquerque, New Mexico, United States, 87109

RECRUITING

United States, New York

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States, 10016

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center - NYC

New York, New York, United States, 10065

RECRUITING

United States, Oregon

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

Portland, Oregon, United States, 97239-3098

RECRUITING

United States, Texas

VA North Texas Health Care System, Nuclear Medicine Service

Dallas, Texas, United States, 75216

RECRUITING

United States, Texas

The University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

RECRUITING

United States, Texas

U.T. MD Anderson Cancer Center

Houston, Texas, United States, 77030