Metastatic Prostate CancerPhase 1/2CRIUS-1NCT07529717
First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer
A Phase 1/2 study testing AZD8359 in people with Metastatic Prostate Cancer, run by AstraZeneca at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- AZD8359
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 18 May 2026to 17 Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
8 sites in 3 countries
United States4 sites, 1 recruiting
- Recruiting
Research Site
East Brunswick, New Jersey, 08816
- Withdrawn
Research Site
Hackensack, New Jersey, 07601
- Active, not recruiting
Research Site
Orlando, Florida, 32806
- Completed
Research Site
Providence, Rhode Island, 02903
Australia2 sites, 2 recruiting
- Recruiting
Research Site
Darlinghurst, 2010
- Recruiting
Research Site
Melbourne, 3000
South Korea2 sites, 2 recruiting
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 06351
About this study
Official 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
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).
Read the detailed description
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.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- AZD8359
- Keywords
- Prostate, STEAP2, T Cell-engaging Antibody, CD8
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8359Drug
AZD8359 Monotherapy Administration route 1
AZD8359Drug
AZD8359 Monotherapy Administration route 2
AZD8359Drug
AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
AZD8359Drug
AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)
| Study group | Role | What they receive |
|---|---|---|
| Module 1 - Part A (Dose Escalation) | Experimental | Not described Receives: Drug: AZD8359 |
| Module 2 - Part A (Dose Escalation) | Experimental | Not described Receives: Drug: AZD8359 |
| Module 1/2 - Part B1 (Dose Expansion) | Experimental | Not described Receives: Drug: AZD8359 |
| Module 1/2 - Part B2 (Dose Expansion) | Experimental | Not described Receives: Drug: AZD8359 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)
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
Measured: From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
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
Measured: From first study dose to 21 OR 28 days post first dose based on schedule
PSA response rate (Part B only)
Number of participants with a PSA50 response
Measured: Up to 3 years
Secondary outcomes (24)
PSA Response rate (Part A only)
Number of participants with a PSA50 response
Measured: Up to 3 years
PSA Response rate
Number of participants with a PSA90 response
Measured: Up to 3 years
Time to PSA response
Time taken to achieve a PSA response
Measured: Up to 3 years
Duration of PSA response
Time PSA response lasts
Measured: Up to 3 years
Durable PSA response rate
Percentage of participants who have a confirmed PSA response with a duration of at least 6 months
Measured: Up to 3 years
Time to PSA progression
Time to achieve PSA progression after a PSA response
Measured: Up to 3 years
Objective Response Rate (ORR)
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
Measured: Up to 3 years
Duration of Response (DoR)
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
Measured: Up to 3 years
Disease Control Rate (DCR)
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
Measured: 16 Weeks
Time To Response (TTR)
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
Measured: Up to 3 years
Radiographic Progression Free Survival (rPFS)
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
Measured: Up to 3 years
Durable Response Rate (DRR)
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)
Measured: Up to 3 years
Target Lesion Percentage change
Percentage change in Target Lesion size according to RECIST v1.1.
Measured: Up to 3 years
Overall Survival (OS) 12 months
Overall Survival at 12 months
Measured: 12 months
Overall Survival (OS)
Median Overall Survival
Measured: Up to 3 years
Symptomatic Skeletal Related Events (SSRE)
Time to first symptomatic skeletal-related events (SSRE)
Measured: Up to 3 years
Serum Concentration of AZD8359
Serum concentrations of the study drug
Measured: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (Cmax)
Maximum observed plasma concentration of the study drug (Cmax).
Measured: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (AUC)
Area under the plasma concentration-time curve (AUC)
Measured: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (Tmax)
The time it takes for study drug to reach the maximum concentration (Tmax)
Measured: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (Clerance)
The volume of plasma completely cleared of a study drug per unit of time
Measured: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (t1/2)
Terminal elimination half life of study drug (t1/2)
Measured: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Immunogenicity of AZD8359 (ADA)
The number and percentage of participants who develop detectable anti-drug antibodies (ADA)
Measured: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Tumor STEAP2 expression
STEAP2 expression in tumor as measured by immunohistochemistry (IHC)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start18 May 2026
- Primary completion17 Nov 2027 (estimated)
- Study completion17 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a first in human, multicenter, open-label, dose-escalation and dose-expansion study. The study includes 2 Modules; Module 1 is investigating AZD8359 given on its own by one method of administration, and Module 2 is investigating AZD8359 on its own by a different method of administration. The study also has 2 parts: Part A Dose Escalation and Part B Dose Expansion. Part B Dose expansion will assess at least 2 doses or dosing schedules in either module. Participants will be randomised in Part B to one of these cohorts whenever possible
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529717
- Sponsor's protocol ID
- D8040C00001
- Acronym
- CRIUS-1
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07529717
- Acronym / sponsor ID
- CRIUS-1 / D8040C00001
- Conditions
- Metastatic Prostate Cancer
- Keywords
- Prostate, STEAP2, T Cell-engaging Antibody, CD8
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 17 Nov 2027 (estimated)
- Study completion
- 17 Nov 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a first in human, multicenter, open-label, dose-escalation and dose-expansion study. The study includes 2 Modules; Module 1 is investigating AZD8359 given on its own by one method of administration, and Module 2 is investigating AZD8359 on its own by a different method of administration. The study also has 2 parts: Part A Dose Escalation and Part B Dose Expansion. Part B Dose expansion will assess at least 2 doses or dosing schedules in either module. Participants will be randomised in Part B to one of these cohorts whenever possible
| Arm | Type | Receives |
|---|---|---|
| Module 1 - Part A (Dose Escalation) | Experimental | Drug: AZD8359 |
| Module 2 - Part A (Dose Escalation) | Experimental | Drug: AZD8359 |
| Module 1/2 - Part B1 (Dose Expansion) | Experimental | Drug: AZD8359 |
| Module 1/2 - Part B2 (Dose Expansion) | Experimental | Drug: AZD8359 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD8359AZD8359 Monotherapy Administration route 1 | Drug | Module 1 - Part A (Dose Escalation) |
| AZD8359AZD8359 Monotherapy Administration route 2 | Drug | Module 2 - Part A (Dose Escalation) |
| AZD8359AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1) | Drug | Module 1/2 - Part B1 (Dose Expansion) |
| AZD8359AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2) | Drug | Module 1/2 - Part B2 (Dose Expansion) |
Primary outcome
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
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
PSA response rate (Part B only)
Time frame: Up to 3 years
Number of participants with a PSA50 response
24 secondary outcomes
PSA Response rate (Part A only)
Time frame: Up to 3 years
PSA Response rate
Time frame: Up to 3 years
Time to PSA response
Time frame: Up to 3 years
Duration of PSA response
Time frame: Up to 3 years
Durable PSA response rate
Time frame: Up to 3 years
Time to PSA progression
Time frame: Up to 3 years
Objective Response Rate (ORR)
Time frame: Up to 3 years
Duration of Response (DoR)
Time frame: Up to 3 years
Disease Control Rate (DCR)
Time frame: 16 Weeks
Time To Response (TTR)
Time frame: Up to 3 years
Radiographic Progression Free Survival (rPFS)
Time frame: Up to 3 years
Durable Response Rate (DRR)
Time frame: Up to 3 years
Target Lesion Percentage change
Time frame: Up to 3 years
Overall Survival (OS) 12 months
Time frame: 12 months
Overall Survival (OS)
Time frame: Up to 3 years
Symptomatic Skeletal Related Events (SSRE)
Time frame: Up to 3 years
Serum Concentration of AZD8359
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (Cmax)
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (AUC)
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (Tmax)
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (Clerance)
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (t1/2)
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Immunogenicity of AZD8359 (ADA)
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Tumor STEAP2 expression
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD8359 in people with Metastatic Prostate Cancer, run by AstraZeneca at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.