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

Sponsor
Fusion Pharmaceuticals Inc.
Study ID
NCT06909825
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FPI-2265 — DRUG
    PSMA ligand radiolabeled with Ac225
  • Olaparib — DRUG
    Poly (ADP-ribose) polymerase (PARP) inhibitor

Study Details

This study is an open-label, multicenter study designed to investigate the efficacy, safety and tolerability of FPI-2265 (225Ac-PSMA-I\&T) in combination with Olaparib in participants with mCRPC. The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 and Olaparib in participants with metastatic castration-resistant prostate cancer.

Key Dates

First listed
Apr 4, 2025
Start date
Feb 26, 2025
Status verified
Jul 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
85 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    Regimen 1: FPI-2265 (Dose A intravenously \[IV\] every six weeks) plus olaparib (twice daily \[BID\], on Days 1 to 14 of each cycle). Regimen 2: . FPI-2265 (Dose B intravenously \[IV\] every 4 weeks) plus olaparib (twice daily \[BID\], on Days 1 to 14 of each cycle)
  • Experimental: Part B
    Regimen 1: FPI-2265 (Dose A intravenously \[IV\] every six weeks) plus olaparib (g twice daily \[BID\], on Days 1 to 14 of each cycle). Regimen 2: . FPI-2265 (Dose B intravenously \[IV\] every 4 weeks) plus olaparib (twice daily \[BID\], on Days 1 to 14 of each cycle)

Primary Outcome Measure

Evaluate anti-tumour activity of FPI-2265 administered in combination with olaparib [ Time Frame: From first dose until approximately 12 weeks after the first administered dose of FPI-2265 ]

Related Studies