SEACLIFF: AZD0516 for the treatment of metastatic prostate cancer
Research type
Research Study
Full title
A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Metastatic Prostate Cancer (SEACLIFF)
IRAS ID
1012190
Contact name
Roser Sanz Casañas
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Researchers are looking for a better way to treat metastatic prostate cancer. The prostate is a small gland located below the bladder that helps make semen. In people with prostate cancer, the body is not able to control the growth of certain cells in the prostate. These cells, known as cancer cells, can multiply and form tumors. Tumors can impact how organs and the body usually function. Metastatic means the cancer has spread to other parts of the body.
The trial drug AZD0516 is designed to bind to a protein on the surface of many prostate cancer cells called STEAP2. When AZD0516 binds to a cell with STEAP2, it kills that cell. In this trial, researchers want to learn how safe AZD0516 is and how well it works in adults with metastatic prostate cancer.
This is a modular, first-in-human, open-label trial. Modular means that AZD0516 will be studied alone and in combination with other cancer treatments in several trial parts called modules. First-in-human means that this trial will be the first time AZD0516 is given to people. Open-label means the participants, researchers, trial doctors, and other trial staff will know what each participant is receiving.
AZD0516 is given through a needle directly into a vein over a period of time (IV infusion). In Module 2,
participants will receive AZD0516 along with another treatment called AZD9574. AZD9574 is a cancer drug designed to prevent cancer cells from repairing themselves. AZD9574 is taken as a tablet by mouth. More modules studying other treatments may be added later.
This trial may include up to about 283 participants in 10 countries and 50 sites.
The Sponsor of the study is AstraZeneca AB.REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0286
Date of REC Opinion
15 Oct 2025
REC opinion
Further Information Favourable Opinion