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Clinical Trials in the UK / NCT07181161
Recruiting Phase 1/2

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

NCT07181161 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 1/2
Started
2025-10-01
Last updated
2026-08-31

Condition(s) studied

Metastatic Prostate Cancer

Investigational drug(s) / intervention(s)

AZD0516AZD9574

AZD0516: AZD0516 will be administered via intravenous infusion.

AZD9574: AZD9574 will be administered orally.

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Main Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted. * Measurable PSA ≥ 1 μg/L (≥ 1 ng/mL). * Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) within ≤ 28 days before treatment allocation. Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) modulator for participants who have not undergone bilateral orchiectomy must be initiated at least 2 weeks prior to consent and must continue throughout the study. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1. * Adequate organ and marrow function in the absence of blood transfusion or growth factor support (within 21 days prior to the scheduled first dose of study intervention). * Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumour sample is mandatory. * Documented current evidence of metastatic prostate cancer * Life expectancy of at least 12 weeks in the opinion of the investigator * Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria: 1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the screening visit should be ≥ 1 μg/L (1 ng/mL). 2. Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3). 3. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression. Main Exclusion Criteria: * Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to study enrolment. * History of leptomeningeal carcinomatosis. * Unresolved toxicities of Grade ≥ 2 (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy). * Uncontrolled intercurrent illness within the last 12 months. * Cardiovascular disorder (History of arrhythmia, uncontrolled hypertension, symptomatic hypotension, history of brain perfusion problems, symptomatic heart failure, prior or current cardiomyopathy, severe valvular heart disease) * History of malignancy * History of non-infectious interstitial lung disease (ILD)/pneumonitis * Active infection exclusions, including tuberculosis and infections with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV). * Any known predisposition to bleeding * Clinically severe pulmonary compromise * Participants with Myelodysplastic syndrome (MDS)/Acute Myeloid Leukemia (AML) or with features suggestive of MDS/AML. * Previous treatment with a STEAP2 targeting modality, chemotherapeutic agent that inhibits topoisomerase activity or metabolic enzymes.

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
Research Site Fayetteville Arkansas Recruiting
Research Site Los Angeles California Recruiting
Research Site Towson Maryland Suspended
Research Site Boston Massachusetts Recruiting
Research Site Ann Arbor Michigan Recruiting
Research Site Detroit Michigan Recruiting
Research Site Buffalo New York Suspended
Research Site New York New York Recruiting
Research Site Providence Rhode Island Recruiting
Research Site Myrtle Beach South Carolina Recruiting
Research Site Houston Texas Recruiting
Research Site Barretos Brazil Not Yet Recruiting
Research Site Porto Alegre Brazil Not Yet Recruiting
Research Site São Paulo Brazil Not Yet Recruiting
Research Site Changsha China Not Yet Recruiting
Research Site Chengdu China Not Yet Recruiting
Research Site Wuhan China Not Yet Recruiting
Research Site Lyon France Withdrawn
Research Site Montpellier France Withdrawn
Research Site Saint-Herblain France Withdrawn
Research Site Suresnes France Withdrawn
Research Site Villejuif France Withdrawn
Research Site Milan Italy Not Yet Recruiting
Research Site Milan Italy Not Yet Recruiting
Research Site Milan Italy Not Yet Recruiting
Research Site Naples Italy Not Yet Recruiting
Research Site Roma Italy Not Yet Recruiting
Research Site Rozzano Italy Not Yet Recruiting
Research Site Chūōku Japan Recruiting
Research Site Kashiwa Japan Not Yet Recruiting
Research Site Kōtoku Japan Recruiting
Research Site Koszalin Poland Not Yet Recruiting
Research Site Piotrkow Trybunalski Poland Not Yet Recruiting
Research Site Przemyśl Poland Not Yet Recruiting
Research Site Seoul South Korea Not Yet Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Not Yet Recruiting
Research Site Barcelona Spain Recruiting

+ 12 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07181161 on ClinicalTrials.gov ↗ ← All trials in the UK