A Phase 1/2 interventional study of AZD0516 and AZD9574 in Metastatic Prostate Cancer, sponsored by AstraZeneca. Recruiting at 52 sites in 10 countries. Open to male participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and/or in combination with other anti-cancer agents for treatment of metastatic prostate cancer.
This is a first-in-human modular, Phase I/IIa, open-label, multi-centre study of AZD0516 in participants with metastatic prostate cancer. The study will consist of individual modules, each evaluating the safety, tolerability, preliminary efficacy, PK, pharmacodynamic, and immunogenicity of AZD0516.
Module 1: Evaluates AZD0516 as monotherapy. It may include 3 parts, Part A- Dose Escalation, Part B- Dose Optimisation, and Part C- Efficacy Expansion.
Module 2: Evaluates AZD0516 in combination with AZD9574. It may include 2 parts, Part A - Dose Escalation and Part B Dose Optimisation.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 283 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with mCRPC will receive AZD0516 monotherapy.
Drug: AZD0516
Participants with mCRPC will receive AZD0516 in combination with AZD9574.
Drug: AZD0516 · Drug: AZD9574
AZD0516 will be administered via intravenous infusion.
AZD9574 will be administered orally.
Module 1 and 2: Parts A and B: Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interests (AESIs)
Part A: To assess the safety and tolerability and to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) of AZD0516 as monotherapy and in combination with anti-cancer agents. Part B: To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.
Time frame: From Day 1 up to approximately 3 years
Module 1 and 2: Part A: Number of participants with Dose Limiting Toxicities (DLTs)
To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.
Time frame: From Day 1 up to end of DLT period (approximately 21 days)
Module 1: Parts B and C and Module 2: Part B: Percentage of participants with Prostate-Specific Antigen (PSA) 50 response rate
The PSA50 response rate is defined as the percentage of participants achieving ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result.
Time frame: Up to approximately 2 years
Module 1 and 2: Part A: Percentage of participants with PSA50 response rate
The PSA50 response rate is defined as the percentage of participants achieving ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result.
Time frame: Up to approximately 2 years
Module 1 and 2: Parts A, B and C: Percentage of participants with PSA90 response rate
The PSA90 response rate is defined as the percentage of participants with a confirmed ≥ 90% decrease in PSA from baseline to the lowest post-baseline PSA result.
Time frame: Up to approximately 2 years
Module 1 and 2: Parts A, B and C: Time to PSA 50 response (TTPSA50)
The TTPSA response is defined as the time from the date of first dose of study intervention until the date of first documented PSA50 response (≥ 50% decrease in PSA from baseline, respectively) that is confirmed by a second consecutive PSA assessment at least 3 weeks later.
Time frame: Up to approximately 2 years
Module 1 and 2: Parts A, B and C: Time to PSA response (TTPSA90)
The TTPSA response is defined as the time from the date of first dose of study intervention until the date of first documented PSA90 response (≥ 90% decrease in PSA from baseline, respectively) that is confirmed by a second consecutive PSA assessment at least 3 weeks later.
Time frame: Up to approximately 2 years
Module 1 and 2: Parts A, B and C: Duration of PSA response 50 (DoPSA50)
The DoPSA50 is defined as the time from the date of first documented PSA50 response, that is subsequently confirmed by a second consecutive PSA assessment at least 3 weeks later, until the date of documented PSA progression.
Time frame: Up to approximately 2 years
Module 1 and 2: Parts A, B and C: Duration of PSA response 90 (DoPSA90)
The DoPSA90 is defined as the time from the date of first documented PSA90 response, that is subsequently confirmed by a second consecutive PSA assessment at least 3 weeks later, until the date of documented PSA progression.
Time frame: Up to approximately 2 years
Module 1 and 2: Parts A, B and C: Percentage of participants with Durable PSA response rate 50 (DRRPSA50)
The DRRPSA50 is defined as the percentage of participants who have a documented PSA50 response that is subsequently confirmed by a second consecutive PSA assessment at least 3 weeks later, with a duration of at least 6 months.
Time frame: Up approximately 2 years
Module 1 and 2: Parts A, B and C: Percentage of participants with Durable PSA response rate 90 (DRRPSA90)
The DRRPSA90 is defined as the percentage of participants who have a documented PSA90 response that is subsequently confirmed by a second consecutive PSA assessment at least 3 weeks later, with a duration of at least 6 months.
Time frame: Up to approximately 2 years
Module 1 and 2: Parts A, B and C: Time to PSA Progression (TTPSA)
TTPSA progression is defined as time from the date of first dose of study intervention until the date of documented PSA progression or the last PSA result in the absence of progression.
Time frame: Up to approximately 2 years
Module 1 and 2: Parts A, B and C: Percentage change from baseline in PSA levels
The percentage change from baseline in PSA levels will be assessed.
Time frame: Up to approximately 2 years
Module 1 and 2: Parts A, B and C: Percentage of participants with Overall Response Rate (ORR)
The ORR is defined as the percentage of participants with a confirmed tumour response of Complete Response (CR) or Partial Response (PR).
Time frame: Up to approximately 3 years
Module 1 and 2: Parts A, B and C: Percentage of participants with Best Overall Response (BOR)
The BOR is defined as the best overall visit response achieved by participant.
Time frame: Up to approximately 3 years
Module 1 and 2: Parts A, B and C: Duration of Response (DoR)
The DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until the date of radiographic disease progression or censoring.
Time frame: Up to approximately 3 years
Module 1 and 2: Parts A, B and C: Percentage of participants with Durable Response Rate (DRR)
The DRR is defined as the percentage of participants who have a confirmed response with a duration of at least 6 months.
Time frame: Up to approximately 3 years
Module 1 and 2: Parts A, B and C: Percentage of participants with Disease Control Rate (DCR)
The DCR is defined as the percentage of participants who have a BOR of confirmed CR or PR or Stable Disease (SD).
Time frame: Up to approximately 3 years
Module 1 and 2: Parts A, B and C: Time to Response (TTR)
The TTR is defined as the time from the date of first dose of study intervention until the date of first documented objective response, which is subsequently confirmed.
Time frame: Up to approximately 3 years
Module 1 and 2: Parts A, B and C: Percentage Change in Tumour Size
The best percentage change from baseline in tumour size is the largest decrease (or smallest increase) from baseline for a participant, using response evaluation criteria in solid tumors (RECIST) v1.1 assessments.
Time frame: Up to approximately 3 years
Module 1 and 2: Parts A, B and C: Radiographic Progression-free Survival (rPFS)
rPFS is defined as the time from date of first dose of study intervention until the date of objective disease progression according to RECIST v1.1 (for soft tissue disease) and prostate cancer working group 3 (PCWG3) criteria (for bone disease) as assessed by the investigator at the local site, or death (by any cause in the absence of progression).
Time frame: Up to approximately 3 years
Module 1 and 2: Parts A, B and C: Overall Survival (OS)
OS is defined as the time from date of first dose of study intervention until death due to any cause.
Time frame: Up to approximately 3 years
Module 1 and 2: Part A and B: Changes in Plasma concentration of AZD0516
To characterise the pharmacokinetics (PK) of AZD0516 when given as monotherapy and in combination with anti-cancer agents.
Time frame: From Day 1 up to approximately 3 years
Module 1 and 2: Parts A and B: Area under concentration-time curve (AUC)
To characterise the PK (AUC) of AZD0516 when given as monotherapy and in combination with anti-cancer agents.
Time frame: From Day 1 up to approximately 3 years
Module 1 and 2: Parts A and B: Maximum observed drug concentration (Cmax)
To characterise the PK (Cmax) of AZD0516 when given as monotherapy and in combination with anti-cancer agents.
Time frame: From Day 1 up to approximately 3 years
Module 1 and 2: Parts A and B: Time to reach maximum observed concentration (tmax)
To characterise the PK (tmax) of AZD0516 when given as monotherapy and in combination with anti-cancer agents.
Time frame: From Day 1 up to approximately 3 years
Module 1 and 2: Parts A and B: Tobal Body Clearance (CL)
To characterise the PK (CL) of AZD0516 when given as monotherapy and in combination with anti-cancer agents.
Time frame: From Day 1 up to approximately 3 years
Module 1 and 2: Parts A and B: Half-life (t1/2)
To characterise the PK (t1/2) of AZD0516 when given as monotherapy and in combination with anti-cancer agents.
Time frame: From Day 1 up to approximately 3 years
Module 1 and 2: Parts A and B: Plasma concentration of total antibody (conjugated and unconjugated)
This refers to the total amount of antibody present in a sample, regardless of whether it's attached to a drug (conjugated) or not (unconjugated). It includes a) Antibodies that are linked to the drug(conjugated antibodies) b) Antibodies that are not linked to any drug (unconjugated antibodies). This measurement gives an overall picture of the antibody concentration, which is important for understanding the pharmacokinetics of the ADC.
Time frame: From Day 1 up to approximately 3 years
Module 1 and 2: Parts A and B: Plasma concentration of total unconjugated payload
The "payload" typically refers to the cytotoxic drug that is attached to the antibody in an antibody drug conjugate (ADC). "Unconjugated payload" means the drug molecules that are not attached to any antibody. "Total unconjugated payload" refers to the total amount of free drug present in the sample. This measurement is crucial for assessing the stability of the ADC and understanding how much of the drug has been released from the antibody.
Time frame: From baseline up to approximately 3 years
Module 1 and 2: Parts A and B: Change from baseline in STEAP2 tumour expression
Target expression of STEAP2 will be evaluated using an analytically validated IHC assay.
Time frame: From baseline up to approximately 3 years
Module 1 and 2: Parts A and B: Association of STEAP2 expression with AZD0516 response
Expression of STEAP2 will be evaluated using an analytically validated IHC assay.
Time frame: From baseline up to approximately 3 years
Module 1 and 2: Parts A and B: Number of participants with positive antidrug antibodies (ADAs)
To determine the immunogenicity of AZD0516 as monotherapy and in combination with anti-cancer agents.
Time frame: Up to approximately 3 years
Module 1: Part C: Number of participants with AEs, SAEs and AESIs
To further assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.
Time frame: From Day 1 up to approximately 3 years
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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.
Supporting information: Study protocol, Statistical analysis plan
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.
Data sharing details ↗ · vivli.org
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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