A Phase 1/2 interventional study of AZD8359 and AZD8359 in Metastatic Prostate Cancer, sponsored by AstraZeneca. Recruiting at 8 sites in 3 countries. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
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).
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 42 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: AZD8359
Drug: AZD8359
Drug: AZD8359
Drug: AZD8359
AZD8359 Monotherapy Administration route 1
AZD8359 Monotherapy Administration route 2
AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)
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
PSA Response rate (Part A only)
Number of participants with a PSA50 response
Time frame: Up to 3 years
PSA Response rate
Number of participants with a PSA90 response
Time frame: Up to 3 years
Time to PSA response
Time taken to achieve a PSA response
Time frame: Up to 3 years
Duration of PSA response
Time PSA response lasts
Time frame: Up to 3 years
Durable PSA response rate
Percentage of participants who have a confirmed PSA response with a duration of at least 6 months
Time frame: Up to 3 years
Time to PSA progression
Time to achieve PSA progression after a PSA response
Time frame: Up to 3 years
Objective Response Rate (ORR)
Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease
Time frame: Up to 3 years
Duration of Response (DoR)
Time from the date of first Objective Response (OR) until date disease progression or death in the absence of disease progression according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease
Time frame: Up to 3 years
Disease Control Rate (DCR)
Percentage of participants who have a Best Overall Response (BOR) of confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease
Time frame: 16 Weeks
Time To Response (TTR)
Time from study drug administration date until the date of first Objective Response (OR) according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease
Time frame: Up to 3 years
Radiographic Progression Free Survival (rPFS)
The time from the start of study treatment (Part A) or date of randomization (Part B) until disease progression or death in the absence of disease progression according to RECIST 1.1 for soft tissue disease and PCWG3 for bone disease
Time frame: Up to 3 years
Durable Response Rate (DRR)
Percentage of participants who have a confirmed best overall response of Complete Response or Partial Response with a duration at specific milestones (e.g., 3 months, 6 months, 12 months)
Time frame: Up to 3 years
Target Lesion Percentage change
Percentage change in Target Lesion size according to RECIST v1.1.
Time frame: Up to 3 years
Overall Survival (OS) 12 months
Overall Survival at 12 months
Time frame: 12 months
Overall Survival (OS)
Median Overall Survival
Time frame: Up to 3 years
Symptomatic Skeletal Related Events (SSRE)
Time to first symptomatic skeletal-related events (SSRE)
Time frame: Up to 3 years
Serum Concentration of AZD8359
Serum concentrations of the study drug
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (Cmax)
Maximum observed plasma concentration of the study drug (Cmax).
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (AUC)
Area under the plasma concentration-time curve (AUC)
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (Tmax)
The time it takes for study drug to reach the maximum concentration (Tmax)
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (Clerance)
The volume of plasma completely cleared of a study drug per unit of time
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Pharmacokinetics of AZD8359 (t1/2)
Terminal elimination half life of study drug (t1/2)
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Immunogenicity of AZD8359 (ADA)
The number and percentage of participants who develop detectable anti-drug antibodies (ADA)
Time frame: From first dose through Day 28 after the last study-drug dose, at predefined intervals
Tumor STEAP2 expression
STEAP2 expression in tumor as measured by immunohistochemistry (IHC)
Time frame: Up to 3 years
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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