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NCT07181161PHASE1, PHASE2Recruiting

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

AstraZeneca

Start Date

10/1/2025

Completion Date

1/18/2029

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 Criteria

Age Range: 18 years to 130 years

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.

Interventions

DRUG

AZD0516

DRUG

AZD9574

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Conditions

Metastatic Prostate Cancer

Locations

Research Site

Fayetteville, Arkansas 72703

United States

Research Site

Los Angeles, California 90095

United States

Research Site

Towson, Maryland 21204

United States

Research Site

Boston, Massachusetts 02114

United States

Research Site

Ann Arbor, Michigan 48109

United States

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Detroit, Michigan 48201

United States

Research Site

Buffalo, New York 14263

United States

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New York, New York 10065

United States

Research Site

Providence, Rhode Island 02906

United States

Research Site

Myrtle Beach, South Carolina 29572

United States

Research Site

Houston, Texas 77030

United States

Research Site

Barretos, 14784-400

Brazil

Research Site

Porto Alegre, 90035-001

Brazil

Research Site

São Paulo, 01401-002

Brazil

Research Site

Changsha, 410013

China

Research Site

Chengdu, 610041

China

Research Site

Wuhan, 430022

China

Research Site

Lyon, 69008

France

Research Site

Montpellier, 34298

France

Research Site

Saint-Herblain, 44805

France

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Suresnes, 92151

France

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Villejuif, 94805

France

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Milan, 20132

Italy

Research Site

Milan, 20133

Italy

Research Site

Milan, 20141

Italy

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Naples, 80131

Italy

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Roma, 00168

Italy

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Rozzano, 20089

Italy

Research Site

Chūōku, 104-0045

Japan

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Kashiwa, 277-8577

Japan

Research Site

Kōtoku, 135-8550

Japan

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Koszalin, 75-581

Poland

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Piotrkow Trybunalski, 97-300

Poland

Research Site

Przemyśl, 37-700

Poland

Research Site

Seoul, 03080

South Korea

Research Site

Seoul, 03722

South Korea

Research Site

Seoul, 06351

South Korea

Research Site

Seoul, 06591

South Korea

Research Site

Seoul, 5505

South Korea

Research Site

Barcelona, 08035

Spain

Research Site

Barcelona, 08036

Spain

Research Site

Barcelona, 08041

Spain

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L'Hospitalet de Llobregat, 08908

Spain

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Madrid, 28027

Spain

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Pamplona, 31005

Spain

Research Site

Santander, 39008

Spain

Research Site

Valencia, 46009

Spain

Research Site

Cambridge, CB2 0QQ

United Kingdom

Research Site

London, EC1A 7BE

United Kingdom

Research Site

London, SE1 9RT

United Kingdom

Research Site

Plymouth, PL6 8DH

United Kingdom

Research Site

Sutton, SM2 5PT

United Kingdom