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NCT Number: NCT07529717

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

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).

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Key information

Conditions

Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, Darlinghurst, Australia

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About this study

This is a first-in-human, modular, Phase I/II, open label, multicenter study of AZD8359, in adult participants with metastatic prostate cancer. The study will consist of study modules, each evaluating the the safety, tolerability, preliminary efficacy, immune cell activation and anti-tumor activity of AZD8359. The study will also characterize the pharmacokinetics and immunogenicity of AZD8359.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

AZD8359

Drug

AZD8359 Monotherapy Administration route 1

Primary outcomes

  1. Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)

    Time frame: From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)

    Number of participants with AEs, AESIs, SAEs, including AEs leading to discontinuation of study intervention and clinically significant alterations from baseline in laboratory parameters, vital signs, ECGs and physical examination results

  2. Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)

    Time frame: From first study dose to 21 OR 28 days post first dose based on schedule

    A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness

  3. PSA response rate (Part B only)

    Time frame: Up to 3 years

    Number of participants with a PSA50 response

Secondary outcomes

  1. PSA Response rate (Part A only)

    Time frame: Up to 3 years

    Number of participants with a PSA50 response

  2. PSA Response rate

    Time frame: Up to 3 years

    Number of participants with a PSA90 response

  3. Time to PSA response

    Time frame: Up to 3 years

    Time taken to achieve a PSA response

  4. Duration of PSA response

    Time frame: Up to 3 years

    Time PSA response lasts

  5. Durable PSA response rate

    Time frame: Up to 3 years

    Percentage of participants who have a confirmed PSA response with a duration of at least 6 months

  6. Time to PSA progression

    Time frame: Up to 3 years

    Time to achieve PSA progression after a PSA response

  7. Objective Response Rate (ORR)

    Time frame: Up to 3 years

    Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease

  8. Duration of Response (DoR)

    Time frame: Up to 3 years

    Time from the date of first Objective Response (OR) until date disease progression or death in the absence of disease progression according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease

  9. Disease Control Rate (DCR)

    Time frame: 16 Weeks

    Percentage of participants who have a Best Overall Response (BOR) of confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease

  10. Time To Response (TTR)

    Time frame: Up to 3 years

    Time from study drug administration date until the date of first Objective Response (OR) according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease

  11. Radiographic Progression Free Survival (rPFS)

    Time frame: Up to 3 years

    The time from the start of study treatment (Part A) or date of randomization (Part B) until disease progression or death in the absence of disease progression according to RECIST 1.1 for soft tissue disease and PCWG3 for bone disease

  12. Durable Response Rate (DRR)

    Time frame: Up to 3 years

    Percentage of participants who have a confirmed best overall response of Complete Response or Partial Response with a duration at specific milestones (e.g., 3 months, 6 months, 12 months)

  13. Target Lesion Percentage change

    Time frame: Up to 3 years

    Percentage change in Target Lesion size according to RECIST v1.1.

  14. Overall Survival (OS) 12 months

    Time frame: 12 months

    Overall Survival at 12 months

  15. Overall Survival (OS)

    Time frame: Up to 3 years

    Median Overall Survival

  16. Symptomatic Skeletal Related Events (SSRE)

    Time frame: Up to 3 years

    Time to first symptomatic skeletal-related events (SSRE)

  17. Serum Concentration of AZD8359

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

    Serum concentrations of the study drug

  18. Pharmacokinetics of AZD8359 (Cmax)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

    Maximum observed plasma concentration of the study drug (Cmax).

  19. Pharmacokinetics of AZD8359 (AUC)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

    Area under the plasma concentration-time curve (AUC)

  20. Pharmacokinetics of AZD8359 (Tmax)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

    The time it takes for study drug to reach the maximum concentration (Tmax)

  21. Pharmacokinetics of AZD8359 (Clerance)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

    The volume of plasma completely cleared of a study drug per unit of time

  22. Pharmacokinetics of AZD8359 (t1/2)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

    Terminal elimination half life of study drug (t1/2)

  23. Immunogenicity of AZD8359 (ADA)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

    The number and percentage of participants who develop detectable anti-drug antibodies (ADA)

  24. Tumor STEAP2 expression

    Time frame: Up to 3 years

    STEAP2 expression in tumor as measured by immunohistochemistry (IHC)

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: CRIUS-1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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