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
Start Date
1/27/2026
Completion Date
1/26/2029
Summary
ANDROMEDA is a first-in-human, Phase I/II, open-label, multicenter study of AZD9750 in participants with metastatic prostate cancer. The trial evaluates safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AZD9750 as monotherapy and in combination with saruparib.
Detailed Description
This first-in-human (FiH), Phase I/II, open-label, multicenter study will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9750 as monotherapy and in combination with saruparib in participants with metastatic prostate cancer. Additional combinations with other anticancer agents may be added via protocol amendment as separate modules. The study follows a modular design, allowing initial assessment of safety, tolerability, and preliminary efficacy across multiple treatment arms. Each Module has 2 parts: Part A (monotherapy dose escalation or combination dose finding) and Part B (monotherapy dose optimization and expansion or combination dose expansion). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention occur.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AZD9750
AZD5305
Conditions
Locations
Research Site
Duarte, California 91010
United States
Research Site
San Francisco, California 94143
United States
Research Site
Tampa, Florida 33612
United States
Research Site
Boston, Massachusetts 02114
United States
Research Site
St Louis, Missouri 63108
United States
Research Site
Myrtle Beach, South Carolina 29572
United States
Research Site
Nashville, Tennessee 37203
United States
Research Site
Salt Lake City, Utah 84112
United States
Research Site
Melbourne, 3000
Australia
Research Site
Calgary, Alberta T2N 5G2
Canada
Research Site
Vancouver, British Columbia V5Z 1H7
Canada
Research Site
Chengdu, 610041
China
Research Site
Chūōku, 104-0045
Japan
Research Site
Kashiwa, 227-8577
Japan
Research Site
Amsterdam, 1066CX
Netherlands
Research Site
Rotterdam, 3015 GD
Netherlands
Research Site
Barcelona, 8035
Spain
Research Site
Cambridge, CB2 2QQ
United Kingdom