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First-in-Human Study of AZD8359 for Metastatic Prostate Cancer

This study is testing an experimental treatment called AZD8359 for metastatic prostate cancer (cancer that has spread to other parts of the body). Researchers want to learn about the safety, how well it's tolerated, and how effective AZD8359 is. The study will involve different ways of giving AZD8359 and will test various dose levels and schedules. To join, you must be a man between 18 and 100 years old with a confirmed diagnosis of prostate cancer that has spread, and your cancer must have progressed recently. The study will measure side effects and how well the treatment shrinks the cancer (PSA response rate). The current status of the study is unclear, and it plans to enroll 42 participants.

Study design
This is a first-in-human, open-label (meaning you and your doctors will know which treatment you are receiving) study with different modules and two parts. It plans to enroll 42 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for adverse events from the time you agree to participate until 90 days after your last dose, up to 3 years. PSA response will be measured for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07529717

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~42 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:AZD8359

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)
Measured over From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)
+2 more outcomes measured

Conditions

Metastatic Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

8 sites across 5 states
New Jersey2
Australia2
South Korea2
Florida1
Rhode Island1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

What this trial measures

  • Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)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)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)Up to 3 years

    Number of participants with a PSA50 response