Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is currently in Phase 2 clinical development, evaluated in combination with olaparib in patients with this condition. The drug is not yet approved and remains under clinical investigation.
FPI-2265 is a small molecule that targets prostate-specific membrane antigen (PSMA), as indicated by its alternative name 225Ac-PSMA-I&T. It is being studied in combination with olaparib for metastatic castration-resistant prostate cancer. The drug is currently in Phase 2 clinical trials.
FPI-2265 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 2 clinical development for metastatic castration-resistant prostate cancer. AstraZeneca is conducting a clinical trial of FPI-2265 in combination with olaparib.
FPI-2265 is in Phase 2 clinical development. It is an investigational drug being studied for metastatic castration-resistant prostate cancer and has not been approved by regulatory authorities. The drug is currently being evaluated in an active clinical trial that is not yet recruiting participants.
FPI-2265 is being studied in a Phase 2 clinical trial with the identifier NCT06909825. This trial, titled "FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)", is active but not recruiting, with an enrollment of 85 male patients aged 18 years and older in Australia.
Yes, FPI-2265 is also known as 225Ac-PSMA-I&T. This alternative name reflects its mechanism as a PSMA-targeting agent. The drug is being studied in Phase 2 clinical trials for metastatic castration-resistant prostate cancer, in combination with olaparib.