First-in-human AZD8359 STEAP2 TCE in metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, modular Phase I/II study evaluating AZD8359 delivered by different methods in adults with metastatic prostate cancer. Part A tests multiple dose levels to find safe and tolerable regimens, while Part B expands to broader dosing in a larger group. The study will look at safety, tolerability, preliminary signs of anti-tumor activity, and how the drug behaves in the body, including immune activation and potential immunogenicity.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  East Brunswick, New Jersey, United States Recruiting
• Research Site
  Darlinghurst, Australia Recruiting
• Research Site
  Melbourne, Australia Recruiting
• Research Site
  Seoul, South Korea Recruiting
• Research Site
  Seoul, South Korea Recruiting
• Research Site
  Orlando, Florida, United States Active not recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.