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

NCT07529717 · tracked via the Priya Life Science South Korea tracker

Sponsor

AstraZeneca

Phase

Phase 1/2

Started

2026-05-18

Last updated

2026-09-09

Condition(s) studied

Metastatic Prostate Cancer

Investigational drug(s) / intervention(s)

AZD8359AZD8359AZD8359AZD8359

AZD8359: AZD8359 Monotherapy Administration route 1

AZD8359: AZD8359 Monotherapy Administration route 2

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

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

Study 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

Sex

MALE

Min age

18 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (8)

Facility	City	Region	Status
Research Site	Orlando	Florida	Recruiting
Research Site	East Brunswick	New Jersey	Recruiting
Research Site	Hackensack	New Jersey	Not Yet Recruiting
Research Site	Providence	Rhode Island	Recruiting
Research Site	Darlinghurst	Australia	Recruiting
Research Site	Melbourne	Australia	Recruiting
Research Site	Seoul	South Korea	Recruiting
Research Site	Seoul	South Korea	Recruiting

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Other trials for the same condition

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer Recruiting

Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer Recruiting

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC Active, not recruiting

A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07529717 on ClinicalTrials.gov ↗ ← All trials in South Korea