RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07529717

Registry updated: 2026-10-09

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Description

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).

Interventions

AZD8359 (Drug)
AZD8359 Monotherapy Administration route 1
AZD8359 (Drug)
AZD8359 Monotherapy Administration route 2
AZD8359 (Drug)
AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
AZD8359 (Drug)
AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)

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

Conditions

Metastatic Prostate Cancer

Locations

Research Site — Orlando, Florida, United States
Research Site — East Brunswick, New Jersey, United States
Research Site — Hackensack, New Jersey, United States
Research Site — Providence, Rhode Island, United States
Research Site — Darlinghurst, Australia
Research Site — Melbourne, Australia
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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