A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Metastatic Prostate Cancer
AstraZeneca
Summary
The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and/or in combination with other anti-cancer agents for treatment of metastatic prostate cancer.
Description
This is a first-in-human modular, Phase I/IIa, open-label, multi-centre study of AZD0516 in participants with metastatic prostate cancer. The study will consist of individual modules, each evaluating the safety, tolerability, preliminary efficacy, PK, pharmacodynamic, and immunogenicity of AZD0516. Module 1: Evaluates AZD0516 as monotherapy. It may include 3 parts, Part A- Dose Escalation, Part B- Dose Optimisation, and Part C- Efficacy Expansion. Module 2: Evaluates AZD0516 in combination with AZD9574. It may include 2 parts, Part A - Dose Escalation and Part B Dose Optimisation.
Eligibility
- Age range