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Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Metastatic Prostate Cancer

NCT07181161•AstraZeneca

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - 130 years

Sex

MALE

Healthy Volunteers

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 more criteria

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
+2 more criteria

Locations (51)

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

Key Dates

Start Date

October 1, 2025

Primary Completion Date

January 18, 2029

Completion Date

January 18, 2029

Last Updated

March 6, 2026

Enrollment

177

ESTIMATED participants

Conditions

Metastatic Prostate Cancer

Interventions

AZD0516

DRUG

AZD9574

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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