ANDROMEDA
Research type
Research Study
Full title
A Phase I/II, Modular, Open-Label, Multi-Centre Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD9750 as Monotherapy and in Combination with Other Anticancer Agents in Participants with Metastatic Prostate Cancer (ANDROMEDA)
IRAS ID
1013440
Contact name
Niloufar Davoudi
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2024-516976-14
Clinicaltrials.gov Identifier
Research summary
In prostate cancer, a hormone called testosterone can cause cancer cells to grow and spread. Treatments that lower the amount of testosterone in the body can help men with prostate cancer. For some men, the cancer can still come back and spread to other parts of the body, including the bones, this is known as metastatic prostate cancer.
The study treatment AZD9750 is designed to stop prostate cancer from growing by removing a protein called androgen receptor (AR) from tumor cells. AR allows tumor cells to respond to testosterone. Without AR, testosterone is not able to promote the growth of the tumor cells. It also tests AZD9750 together with saruparib, a tablet that damages cancer cell DNA.
This first time in human study asks: how safe AZD9750 is and how well it works in people with metastatic prostate cancer when given with or without other anticancer drugs like saruparib.
This open label, Phase I/II, multi centre study has 2 modules:
• Module 1: AZD9750 on its own.
• Module 2: AZD9750 together with saruparib.Each module has two parts:
• Part A: Small groups start at a low dose. Doctors will look at the results and decide whether to increase the dose in the next group.
• Part B: More people receive the dose (or dose combination) selected from Part A to better understand safety and early signs of benefit.Participants will have regular blood and urine tests (including PSA), heart checks (ECGs), CT/MRI and bone scans, vital signs and physical examinations, and may have blood samples for drug levels. Treatment continues until their cancer gets worse, they have medical problems related to the trial treatment, or they leave the trial for another reason.
Around 302 people (potentially up to ~322) with metastatic prostate cancer may join; some may have specific changes in the AR gene.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
26/NE/0014
Date of REC Opinion
9 Mar 2026
REC opinion
Further Information Favourable Opinion