A Phase 2, Open-label, Multi-centre Study of FPI-2265 and Olaparib in Participants with mCRPC

• Research type

  Research Study

• Full title

  A Phase 2, Open-label, Multi-centre, Study of FPI-2265 (225Ac-PSMA-I&T) and Olaparib in Participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).

• IRAS ID

  1009601

• Contact name

  Elvis Osei Tutu

• Contact email

  Regulatory@fusionpharma.com

• Sponsor organisation

  Fusion Pharmaceuticals, Inc.

• Research summary

  This Phase 2 study aims to determine if different dose regimens of an investigational radioactive agent, called FPI-2265, in combination with a cancer drug called olaparib may control metastatic castration-resistant prostate cancer and to test if the combination is safe.
  FPI-2265 targets a protein located on the surface of most prostate cancer cells called prostate-specific membrane antigen (PSMA). FPI-2265 damages these cancer cells, resulting in their death. Olaparib prevents cells from repairing themselves. By preventing repair, the tumour cell may not be able to heal itself after exposure to FPI-2265. Olaparib has been approved by the MHRA for certain types of cancers. However, olaparib use in combination with FPI-2265 is investigational and has not been approved by the MHRA. Patients who qualify for this study will be assigned to one of three dosing regimens, which will be given in treatment cycles. During the first two weeks of the first treatment cycle, participants will have to come to hospital at least three times. Then, they will come to the hospital once every two weeks in subsequent cycles. Participants’ doses of FPI-2265 and treatment cycle lengths will depend on the treatment regimen to which they are assigned. All participants will take 300 mg olaparib by mouth twice a day for the first fourteen days of each treatment cycle. Participation will last approximately 32-36 weeks depending on the dose regimen the participant is assigned to and how many cycles of treatment they receive. After their final dose of FPI-2265, participants will then enter a follow-up period for up to 5 years. Approximately 116 participants will take part in this study at up to 16 study sites in the UK and Australia. Study assessments will include blood and urine samples, physical examinations, CT/MRI scans, PET scans, renal and bone scans and optional bone biopsies.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  25/LO/0183

• Date of REC Opinion

  9 May 2025

• REC opinion

  Further Information Favourable Opinion