NCT06879041

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

A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.

Detailed description

This is a first-in-human, Phase I, non-randomized, open-label clinical trial designed to evaluate AZD2284, AZD2287, and AZD2275. This trial will consist of 2 Parts: Part A (Imaging): * Part A (Cold Antibody Exploration): aims to determine the optimal dosing regimen, with or without unconjugated antibody (AZD2275) pre-administration to improve the biodistribution of AZD2287. * Part A Expansion: aims to explore the prevalence of PSMA and STEAP2 expression by imaging. Part B (Therapeutic): * Part B (Actinium-225 Dose Escalation): aims to assess the safety, tolerability, and efficacy of escalating doses of AZD2284 informed by the optimal dosing regimen identified in Part A. * Part B Expansion Cohorts 1 and 2: aims to explore efficacy of AZD2284.

Conditions

• Metastatic Castration-Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	AZD2287	AZD2287 is administered through intravenous injection.
DRUG	AZD2275	AZD2275 is administered through intravenous infusion.
DRUG	AZD2284	AZD2284 is administered through intravenous injection.

Timeline

• Start date: 2025-03-10
• Primary completion: 2029-04-16
• Completion: 2029-04-16
• First posted: 2025-03-17
• Last updated: 2026-03-17

Locations

15 sites across 3 countries: United States, Australia, South Africa

Regulatory

• FDA-regulated drug study