Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer
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
Interventions
AZD0516
AZD9574
Conditions
Locations
Research Site
Fayetteville, Arkansas 72703
United States
Research Site
Los Angeles, California 90095
United States
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Towson, Maryland 21204
United States
Research Site
Boston, Massachusetts 02114
United States
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Ann Arbor, Michigan 48109
United States
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Detroit, Michigan 48201
United States
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Buffalo, New York 14263
United States
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New York, New York 10065
United States
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Providence, Rhode Island 02906
United States
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Myrtle Beach, South Carolina 29572
United States
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Houston, Texas 77030
United States
Research Site
Barretos, 14784-400
Brazil
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Porto Alegre, 90035-001
Brazil
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São Paulo, 01401-002
Brazil
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Changsha, 410013
China
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Chengdu, 610041
China
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Wuhan, 430022
China
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Lyon, 69008
France
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Montpellier, 34298
France
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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
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Milan, 20133
Italy
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Milan, 20141
Italy
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Naples, 80131
Italy
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Roma, 00168
Italy
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Rozzano, 20089
Italy
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Chūōku, 104-0045
Japan
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Kashiwa, 277-8577
Japan
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Kōtoku, 135-8550
Japan
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Koszalin, 75-581
Poland
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Piotrkow Trybunalski, 97-300
Poland
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Przemyśl, 37-700
Poland
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Seoul, 03080
South Korea
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Seoul, 03722
South Korea
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Seoul, 06351
South Korea
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Seoul, 06591
South Korea
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Seoul, 5505
South Korea
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Barcelona, 08035
Spain
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Barcelona, 08036
Spain
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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
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Santander, 39008
Spain
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Valencia, 46009
Spain
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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