Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer
NCT ID: NCT07181161
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
177 participants
INTERVENTIONAL
2025-10-01
2029-01-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer
NCT00502164
A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT06879041
AZD2171 to Treat Prostate Cancer
NCT00436956
A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs
NCT07336446
An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer
NCT04089553
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: AZD0516 monotherapy
Participants with mCRPC will receive AZD0516 monotherapy.
AZD0516
AZD0516 will be administered via intravenous infusion.
Arm 2: AZD0516 + AZD9574
Participants with mCRPC will receive AZD0516 in combination with AZD9574.
AZD0516
AZD0516 will be administered via intravenous infusion.
AZD9574
AZD9574 will be administered orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD0516
AZD0516 will be administered via intravenous infusion.
AZD9574
AZD9574 will be administered orally.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
130 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Fayetteville, Arkansas, United States
Research Site
Los Angeles, California, United States
Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
Research Site
Providence, Rhode Island, United States
Research Site
Myrtle Beach, South Carolina, United States
Research Site
Houston, Texas, United States
Research Site
Barretos, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Wuhan, , China
Research Site
Lyon, , France
Research Site
Montpellier, , France
Research Site
Saint-Herblain, , France
Research Site
Suresnes, , France
Research Site
Villejuif, , France
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Napoli, , Italy
Research Site
Roma, , Italy
Research Site
Rozzano, , Italy
Research Site
Chūōku, , Japan
Research Site
Kashiwa, , Japan
Research Site
Kōtoku, , Japan
Research Site
Koszalin, , Poland
Research Site
Piotrkow Trybunalski, , Poland
Research Site
Przemyśl, , Poland
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
L'Hospitalet de Llobregat, , Spain
Research Site
Madrid, , Spain
Research Site
Pamplona, , Spain
Research Site
Santander, , Spain
Research Site
Valencia, , Spain
Research Site
Cambridge, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Plymouth, , United Kingdom
Research Site
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-520026-11-00
Identifier Type: OTHER
Identifier Source: secondary_id
D9520C00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.