Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD2265 (FPI-2265)
AZD2265 · 1 trial · 1 indication
To assess the safety and tolerability of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
To assess the safety and tolerability, and characterise the DLTs of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
To further assess the safety and tolerability, and determine the recommended Phase 3 dose (RP3D) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
PSA50 response rate is defined as proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later, and occurring prior to confirmed PSA progression. PSA50 will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
| Arm | Type | Description |
|---|---|---|
| Substudy 1 Part A(SS1A): escalating dose levels of palacaparib in combination with AZD2265(FPI-2265) | EXPERIMENTAL | Participants will receive escalating dose levels of palacaparib (AZD9574) once daily in combination with AZD2265 (FPI-2265) once every 6 weeks (Q6W). |
| Sub study 1 Part B(SS1B): selected dose of palacaparib in combination with AZD2265(FPI-2265) | EXPERIMENTAL | Participants will receive palacaparib (AZD9574) chosen from the DE phase once daily in combination with AZD2265 (FPI-2265) Q6W. |
| SS1B: AZD2265 (FPI-2265) monotherapy | EXPERIMENTAL | Participants will receive AZD2265 (FPI-2265) monotherapy Q6W. |
| SS1B: Docetaxel | ACTIVE_COMPARATOR | Participants will receive docetaxel as a standard of care (SoC) once every 3 weeks (Q3W). |
| Name | Type | Description |
|---|---|---|
| AZD2265 (FPI-2265) | DRUG | AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection. |
| Palacaparib (AZD9574) | DRUG | Palacaparib (AZD9574) will be administered orally. |
| Docetaxel | DRUG | Docetaxel will be administered as an IV infusion. |
| AZD2287 (Imaging agent) | DRUG | AZD2287 will be administered as an IV injection. |
Inclusion Criteria: 1. Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell). 2. Minimum life expectancy of 3 months or more. 3. Eastern Cooperative Oncology Group (ECOG) performance status of O ...
Top 20 of 55 competitors
AZD2265 is an investigational small molecule being studied for the treatment of metastatic prostate cancer. It is a biomarker-selected therapy, meaning trial enrollment is limited to patients whose tumors express a specific molecular marker. It is not approved for any indication and remains in clinical development.
AZD2265 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating the agent in metastatic prostate cancer.
AZD2265 is in Phase 1 clinical development. It is being evaluated in a Phase Ib/II platform study, and the drug has not completed any trials and is not approved by the FDA or any other regulatory agency.
AZD2265 is being studied in NCT07590934, a Phase Ib/II platform study of multiple anti-cancer agents in participants with metastatic prostate cancer. The trial is currently recruiting, has an estimated enrollment of 152 participants, and is active-controlled and randomized. It is being conducted in the United States, Australia, Germany, Italy, South Korea, Spain, and the United Kingdom.
Yes, AZD2265 is also known as FPI-2265. Both names refer to the same investigational small molecule developed by AstraZeneca for metastatic prostate cancer. The dual naming reflects the compound's development history, and it is currently in Phase 1 testing.