Phase I First-in-Human Study Evaluating Safety and Doses of AZD2284, AZD2287, and AZD2275 in Men With Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, and dosing of three drugsAZD2284, AZD2287, and AZD2275in patients with metastatic castration-resistant prostate cancer. This first-in-human, Phase I trial aims to understand how these drugs behave in the body and to explore their potential effects in this advanced prostate cancer population. The study is divided into two parts Part A focuses on imaging and dosing optimization, while Part B focuses on dose escalation and therapeutic evaluation. Participants in Part A receive AZD2287 alone or combined with AZD2275 to find the best dosing approach. In Part B, different doses of AZD2284 are given based on findings from Part A, with several dose levels tested to assess safety and potential effectiveness. Expansion cohorts in Part B further explore the effects of AZD2284 at selected doses. Throughout the study, participants will undergo imaging scans such as SPECTCT, laboratory tests, and monitoring for side effects and drug levels. Researchers will track adverse events, dose-limiting toxicities, and radiation doses, as well as tumor uptake of the drugs. Longer-term outcomes like prostate-specific antigen response, progression-free survival, and overall survival will be followed for up to five years. The total duration of follow-up varies by study part and dose level.

A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer