NCT07529717 First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer
| NCT ID | NCT07529717 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | AstraZeneca |
| Condition | Metastatic Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-05-18 |
| Primary Completion | 2027-11-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2026-05-18 with a primary completion date of 2027-11-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07529717 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 100 Years, studying Metastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07529717 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07529717 currently recruiting?
Yes, NCT07529717 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07529717 trial being conducted?
This trial is being conducted at Orlando, United States, East Brunswick, United States, Hackensack, United States, Providence, United States and 4 additional locations.
Who is sponsoring the NCT07529717 clinical trial?
NCT07529717 is sponsored by AstraZeneca. The trial plans to enroll 42 participants.
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