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RecruitingLast updated: 19 May 2026

CRIUS-1: Evaluating the safety, effectiveness, and recommended dose level of a new type of targeted antibody treatment for people with prostate cancerPhase I/II Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18 - 100

Trial acronym

CRIUS-1

Clinical summary

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.

Who is it for?
You may be eligible for this study if you have adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer. You should also be surgically or medically castrated, and have evidence of disease progression. There are specific criteria regarding prior treatment history for each part of the study, speak with your doctor about whether you may be eligible.

Study details
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 (dose escalation) which will test different dose levels and dosing schedules of AZD8359 to determine which doses are best in terms of safety and side effects.
  • Part B (dose expansion) will further test at least two AZD8359 doses in a larger group of participants.

Conditions

This trial is treating people with prostate cancer who are surgically or medically castrated

Eligibility

Inclusion

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer
  • Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L)
  • PSA value at screening should be ≥ 1ng/mL
  • Evidence of disease progression within 6 months prior to screening
  • Part A Participants should have received at least 2 prior approved systemic therapies for prostate cancer with at least one androgen receptor pathway inhibitor and at least one taxane regimen if amenable
  • Part B Participants should have received an androgen receptor pathway inhibitor for metastatic hormone sensitive prostate cancer or metastatic castration resistant prostate cancer (mCRPC). No prior taxane treatment for mCRPC is allowed for Module 1 and 2 Part B patients
  • Adequate organ function
  • Body weight ≥ 35 kg

Exclusion

  • Any clinically relevant cardiac abnormalities such as QT prolongation or uncontrolled cardiac arrythmias
  • All prior treatment-related adverse events must have resolved to Grade ≤ 2
  • History of Grade ≥ 3 cytokine release syndrome or Grade ≥ 2 immune effector cell-associated neurotoxicity syndrome with prior therapy
  • Active or prior documented autoimmune or inflammatory disorders within the past 3 years
  • Prior exposure to any STEAP2 targeted agents or TCEs for prostate cancer

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific Title

Phase I/II Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer

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