Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer
Start Date
6/3/2026
Completion Date
9/25/2029
Summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic prostate cancer.
Detailed Description
This is a multicentre, open-label and platform study to evaluate multiple anti-cancer agents in participants with metastatic prostate cancer. This platform study will comprise a series of substudies. Each substudy will follow a 2-part structure (unless otherwise stated in the individual substudy): * Part A: A dose escalation (DE) phase to identify dose limiting toxicities (DLTs), characterise safety, PK, pharmacodynamics, preliminary efficacy, and determine biologically and clinically suitable dose levels to proceed into the dose optimisation/expansion. * Part B: A dose optimisation/expansion phase to inform recommended Phase 3 dose (RP3D), explore efficacy with Prostate-specific antigen (PSA) decrease ≥ 50% (PSA50) rate as primary endpoints, alongside continued safety monitoring. Sub-study 1 focuses on a specific combination regimen and it will assess the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumour activity of AZD2265 (FPI-2265) in combination with AZD9574 compared with AZD2265 (FPI-2265) monotherapy and with standard-of-care (SoC) docetaxel chemotherapy in participants with metastatic castration resistant prostate cancer (mCRPC).
Eligibility Criteria
Age Range: 18 years to 99 years
Interventions
AZD2265 (FPI-2265)
AZD9574
Docetaxel
AZD2287 (Imaging agent)
Conditions
Locations
Research Site
Encino, California 91436
United States
Research Site
South Pasadena, California 91030
United States
Research Site
Miami, Florida 33165
United States
Research Site
Tampa, Florida 33612
United States
Research Site
Metairie, Louisiana 70006
United States
Research Site
Minneapolis, Minnesota 55455
United States
Research Site
Omaha, Nebraska 68130
United States
Research Site
New York, New York 10065
United States
Research Site
Portland, Oregon 97239
United States
Research Site
Houston, Texas 77030
United States
Research Site
North Adelaide, 5000
Australia
Research Site
Essen, 45147
Germany
Research Site
Jena, 07747
Germany
Research Site
Rostock, 18057
Germany
Research Site
Tübingen, 72076
Germany
Research Site
Bergamo, 24127
Italy
Research Site
Meldola, 47014
Italy
Research Site
Milan, 20133
Italy
Research Site
Milan, 20141
Italy
Research Site
Roma, 00168
Italy
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, 08028
Spain
Research Site
L'Hospitalet de Llobregat, 08908
Spain
Research Site
Madrid, 28031
Spain
Research Site
Madrid, 28041
Spain
Research Site
Pamplona, 31008
Spain
Research Site
Fulham, SW3 6JJ
United Kingdom
Research Site
Guildford, CU2 7XX
United Kingdom
Research Site
London, WC1E 6DB
United Kingdom
Research Site
Newcastle upon Tyne, NE7 7DN
United Kingdom
Research Site
Oxford, OX3 7LE
United Kingdom