Clinical Trial

First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer

Study acronym: CRIUS-1

Recruiting Phase 1/2

Summary

This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD8359. The study is split into different modules which will look at AZD8359 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels and dosing schedules of AZD8359 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD8359 doses in a larger group of participants (dose expansion).

Protocol Amendment History 3 changes

critical Recruitment opened 2026-05-23

notable Primary completion pushed: 2027-10-11 -> 2027-11-17 2026-05-23

minor Completion pushed: 2027-10-11 -> 2027-11-17 2026-05-23

Trial Details

NCT Number	NCT07529717
Lead Sponsor	AstraZeneca
Conditions	Metastatic Prostate Cancer
Enrollment	42 participants
Start Date	2026-05-18
Primary Completion	2027-11-17 (estimated)
Study Completion	2027-11-17 (estimated)
Updated on ClinicalTrials.gov	2026-08-06