Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD2265 (FPI-2265)
FPI-2265 · 1 trial · 1 indication
The frequency and proportion of participants with PSA50 response will be summarized, where PSA50 is defined as ≥50% decline in PSA level from pre-treatment.
Safety will be assessed by percentage of patient with treatment emergent adverse events and serious adverse events; percentage of patients with SAEs during the first year of the long term follow up and the number of AESIs during the 5 year follow up period. Percentage of patients with interruption of FPI-2265; percentage of patients who discontinue treatment; number and grade for AEs related to study treatment.
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | 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) |
| Part B | EXPERIMENTAL | 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) |
| Name | Type | Description |
|---|---|---|
| FPI-2265 | DRUG | PSMA ligand radiolabeled with Ac225 |
| Olaparib | DRUG | Poly (ADP-ribose) polymerase (PARP) inhibitor |
Inclusion Criteria: 1. Adult male participants with mCRPC that is progressing at the time of study entry 2. ECOG performance status 0-1 and life expectancy of at least three months 3. Must have received at least one novel anti-androgen deprivation therapy 4. Participants with known BRCA mutations s...
FPI-2265 is an investigational small molecule in Phase 2 development for metastatic castration-resistant prostate cancer, an advanced form of prostate cancer that no longer responds to hormone-lowering treatment. It is being developed by AstraZeneca PLC (ticker AZN) and is also known as 225Ac-PSMA-I&T. It has not been approved by the FDA.
FPI-2265 is being studied for use in metastatic castration-resistant prostate cancer, or mCRPC, in adult men aged 18 years and older. The Phase 2 trial evaluates it in combination with olaparib. It is investigational and has not been approved for any indication.
FPI-2265 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the Phase 2 clinical program evaluating the drug in metastatic castration-resistant prostate cancer.
FPI-2265 is in Phase 2 clinical development. One Phase 2 trial is currently active, and no Phase 3 trials or completed trials have been reported. The drug remains investigational and has not received FDA approval for any indication.
FPI-2265 is being evaluated in the Phase 2 trial NCT06909825, titled FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC). The trial is active but not recruiting, has enrolled 85 participants, and is being conducted in Australia in adult men aged 18 years and older.