NCT07529717RecruitingPhase 1/2
First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer
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
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 8 Apr 2026
- Start date
- 18 May 2026
- Primary completion date
- 17 Nov 2027
- Lead sponsor
- AstraZeneca
- Diseases
- Prostate cancer
- NCT number
- NCT07529717
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 42
- From 18 May 2026 to the primary completion date, 17 Nov 2027
- 7 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Lab values
- Any clinically relevant cardiac abnormalities such as QT prolongation or uncontrolled cardiac arrythmias
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Darlinghurst | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | East Brunswick | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Hackensack | United States | Withdrawn |
| - Coordinator of this site? Confirm its status | Orlando | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Providence | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.