Recruiting
Phase 1
Phase 2

AZD8359

Sponsor:

AstraZeneca

Code:

NCT07529717

Conditions

Metastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AZD8359

AZD8359

AZD8359

AZD8359

Study Details

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).

Conditions

Metastatic Prostate Cancer

Study ID

NCT07529717

Start date

May 18, 2026

Status verified date

Sep, 2026

Completion date

Nov 17, 2027

Anticipated

Primary completion date

Nov 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Module 1 - Part A (Dose Escalation)

experimental: Module 2 - Part A (Dose Escalation)

experimental: Module 1/2 - Part B1 (Dose Expansion)

experimental: Module 1/2 - Part B2 (Dose Expansion)

Interventions

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)

Primary outcome measure

  • Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE) [ Time Frame: From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years) ]
  • Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only) [ Time Frame: From first study dose to 21 OR 28 days post first dose based on schedule ]
  • PSA response rate (Part B only) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Orlando, Florida, United States, 32806

Research Site

Recruiting

East Brunswick, New Jersey, United States, 08816

Research Site

Recruiting

Providence, Rhode Island, United States, 02903

More Information

Sponsor

AstraZeneca

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Prostate
  • STEAP2
  • T Cell-engaging Antibody
  • CD8

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-09.