NCT07181161

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	AZD0516	AZD0516 will be administered via intravenous infusion.
DRUG	AZD9574	AZD9574 will be administered orally.

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-01-18
• Completion: 2029-01-18
• First posted: 2025-09-18
• Last updated: 2026-04-08

Locations

51 sites across 10 countries: United States, Brazil, China, France, Italy, Japan, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study