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

NCT07529717 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: D8040C00001
• Study Type: interventional
• Target: 42
• Locations: 3 countries
• Sites: 8

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

Keywords

Prostate, STEAP2, T Cell-engaging Antibody, CD8

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)

  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

  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)

  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

  From first study dose to 21 OR 28 days post first dose based on schedule

• PSA response rate (Part B only)

  Number of participants with a PSA50 response

  Up to 3 years

Secondary Outcomes (24)

• PSA Response rate (Part A only)

  Up to 3 years

• PSA Response rate

  Up to 3 years

• Time to PSA response

  Up to 3 years

• Duration of PSA response

  Up to 3 years

• Durable PSA response rate

  Up to 3 years

Study Arms (4)

Module 1 - Part A (Dose Escalation)

EXPERIMENTAL

Drug: AZD8359

Module 2 - Part A (Dose Escalation)

EXPERIMENTAL

Drug: AZD8359

Module 1/2 - Part B1 (Dose Expansion)

EXPERIMENTAL

Drug: AZD8359

Module 1/2 - Part B2 (Dose Expansion)

EXPERIMENTAL

Drug: AZD8359

Interventions

AZD8359 DRUG

AZD8359 Monotherapy Administration route 1

Module 1 - Part A (Dose Escalation)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Male, as assigned at birth, inclusive of all gender identities
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (8)

Research Site

Orlando, Florida, 32809, United States

Location

Research Site

East Brunswick, New Jersey, 08816, United States

Location

Research Site

Hackensack, New Jersey, 07601, United States

Location

Research Site

Providence, Rhode Island, 02903, United States

Location

Research Site

Darlinghurst, 2010, Australia

Location

Research Site

Melbourne, 3000, Australia

Location

Research Site

Seoul, 03722, South Korea

Location

Research Site

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a first in human, multicenter, open-label, dose-escalation and dose-expansion study. The study includes 2 Modules; Module 1 is investigating AZD8359 given on its own by one method of administration, and Module 2 is investigating AZD8359 on its own by a different method of administration. The study also has 2 parts: Part A Dose Escalation and Part B Dose Expansion. Part B Dose expansion will assess at least 2 doses or dosing schedules in either module. Participants will be randomised in Part B to one of these cohorts whenever possible

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): October 11, 2027
• Study Completion (Estimated): October 11, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Locations

AU (2); KR (2); US (4)