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RecruitingInterventionalPhase 1/Phase 2

Phase I/II Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer

NCT ID: NCT07529717Sponsor: AstraZenecaLast updated: 2026-06-16

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).

Detailed description

This is a first-in-human, modular, Phase I/II, open label, multicenter study of AZD8359, in adult participants with metastatic prostate cancer. The study will consist of study modules, each evaluating the the safety, tolerability, preliminary efficacy, immune cell activation and anti-tumor activity of AZD8359. The study will also characterize the pharmacokinetics and immunogenicity of AZD8359.

Arms & interventions

  • DrugAZD8359

    AZD8359 Monotherapy Administration route 1

  • DrugAZD8359

    AZD8359 Monotherapy Administration route 2

  • DrugAZD8359

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

  • DrugAZD8359

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

Outcome measures

Primary

  • 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

    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)

    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

    Time frame: 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

    Time frame: Up to 3 years

Secondary

  • PSA Response rate (Part A only)

    Time frame: Up to 3 years

  • PSA Response rate

    Time frame: Up to 3 years

  • Time to PSA response

    Time frame: Up to 3 years

  • Duration of PSA response

    Time frame: Up to 3 years

  • Durable PSA response rate

    Time frame: Up to 3 years

  • Time to PSA progression

    Time frame: Up to 3 years

  • Objective Response Rate (ORR)

    Time frame: Up to 3 years

  • Duration of Response (DoR)

    Time frame: Up to 3 years

  • Disease Control Rate (DCR)

    Time frame: 16 Weeks

  • Time To Response (TTR)

    Time frame: Up to 3 years

  • Radiographic Progression Free Survival (rPFS)

    Time frame: Up to 3 years

  • Durable Response Rate (DRR)

    Time frame: Up to 3 years

  • Target Lesion Percentage change

    Time frame: Up to 3 years

  • Overall Survival (OS) 12 months

    Time frame: 12 months

  • Overall Survival (OS)

    Time frame: Up to 3 years

  • Symptomatic Skeletal Related Events (SSRE)

    Time frame: Up to 3 years

  • Serum Concentration of AZD8359

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

  • Pharmacokinetics of AZD8359 (Cmax)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

  • Pharmacokinetics of AZD8359 (AUC)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

  • Pharmacokinetics of AZD8359 (Tmax)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

  • Pharmacokinetics of AZD8359 (Clerance)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

  • Pharmacokinetics of AZD8359 (t1/2)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

  • Immunogenicity of AZD8359 (ADA)

    Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals

  • Tumor STEAP2 expression

    Time frame: Up to 3 years

Eligibility criteria

Sex: MaleAge: 18 Years to 100 YearsHealthy volunteers: No
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 locations (4)

Research Site

Orlando, Florida, 32806

Recruiting

Research Site

East Brunswick, New Jersey, 08816

Not Yet Recruiting

Research Site

Hackensack, New Jersey, 07601

Not Yet Recruiting

Research Site

Providence, Rhode Island, 02903

Not Yet Recruiting
First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer | Cancerify