RecruitingPHASE1INTERVENTIONAL

A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

This is an early-stage study looking at a new treatment called DS9051b for adult patients with advanced adrenal gland cancer (adrenocortical carcinoma) or prostate cancer that has spread and is no longer responding to standard hormone therapy. The main goals are to find out the safest dose of DS9051b, understand any side effects, and see if there are early signs that it might be an effective treatment. This drug is still in the very first stages of testing in humans, so researchers are carefully monitoring participants. If you or someone you know has been diagnosed with these specific cancers, this trial aims to gather important information that could lead to new treatment options in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Daiichi Sankyo

Enrolment target

Start

04 Nov 2025

Estimated completion

01 Mar 2028

Advanced or Metastatic Adrenocortical Carcinoma Metastatic Castration-resistant Prostate Cancer

What is this study about?

This study is investigating a new potential cancer treatment called DS9051b. It's designed for people who have advanced adrenocortical carcinoma, which is a rare cancer of the adrenal glands, or metastatic castration-resistant prostate cancer, which is prostate cancer that has spread to other parts of the body and is no longer controlled by hormone treatments.

This is a 'first-in-human' study, meaning it's one of the first times this drug is being given to people. The main purpose is to carefully check the safety of DS9051b, understand any side effects it might have, and work out the best dose to give. Researchers are also looking for any early hints that the drug might be effective in treating these specific types of cancer.

By taking part in this kind of study, participants help doctors learn more about new drugs. This knowledge is vital for developing future treatments for people living with these challenging conditions. It's an important step in researching new ways to fight cancer.

Key takeaways

This is an early study (Phase 1) of a new drug called DS9051b.
It's for people with advanced adrenal gland cancer or spreading prostate cancer not responding to standard hormone therapy.
The main aims are to check safety, find the best dose, and look for early signs the drug is working.
Participants will receive close medical monitoring.
Your medical history and current health will be thoroughly checked to see if you can take part.

Who may be eligible?

To join this study, participants must be at least 18 years old and have a confirmed diagnosis of either advanced adrenocortical carcinoma or prostate cancer that has spread. Your general health and organ function would need to be good enough to take part.

For those with prostate cancer, you would need to have already received certain hormone therapies and potentially chemotherapy, or be unable to have chemotherapy. Your cancer would also need to show signs of getting worse despite previous treatments.

However, you wouldn't be able to join if you have certain other medical conditions, such as problems with your pituitary gland, an active autoimmune disease needing strong medication, or if you regularly need high doses of certain steroid medications. Your medical team would review all your health information to see if this study is right for you.

Quick self-check

Are you 18 years old or older?
Do you have a confirmed diagnosis of advanced adrenal gland cancer or prostate cancer that has spread?
If you have prostate cancer, have you tried certain hormone therapies?
Are you generally well and able to manage daily activities without much difficulty?
Do you currently require high doses of certain steroid medications for other health conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests and checks to make sure it's safe for you. This includes blood tests and a review of your general health. You would then receive the study drug, DS9051b, likely through injections or infusions, over a period of time, with regular visits to the clinic.

During these visits, the doctors and nurses would monitor you closely for any side effects and check how the treatment is affecting your cancer. This would involve repeat blood tests, scans, and physical examinations. The exact number of visits and the total length of your participation would depend on how you respond to the treatment and the stage of the study, but it would involve regular follow-ups.

Initially, the study aims to find the right dose, so participants might start on different doses. The medical team will keep you fully informed about what to expect at each stage.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of joining this study is that you would be among the first to receive DS9051b, which could potentially help your cancer if it proves effective, though this is not guaranteed. You would also receive very close medical monitoring throughout the study. Potential risks include side effects from the drug, which are currently unknown as it's a new treatment. Any medical procedure or drug carries some risk, and the research team will explain all known and potential risks to you. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (6)

Florida Cancer Specialists
Sarasota, United States· Recruiting
Columbia University
New York, United States· Recruiting
Brown University
Providence, United States· Recruiting
Oncopole Claudius Regaud
Toulouse, France· Recruiting
Centre Oscar Lambret
Villejuif, France· Not yet recruiting
Royal Marsden
London, United Kingdom· Not yet recruiting

Common questions

What is DS9051b?

DS9051b is a new drug being tested to see if it can treat certain types of advanced cancer. It's in the very early stages of development.

What kind of cancers is this study for?

This study is for people with advanced adrenal gland cancer (adrenocortical carcinoma) or prostate cancer that has spread and is no longer responding to standard hormone treatments.

What does a 'Phase 1' study mean?

Phase 1 means it's the first time the drug is being tested in humans. The main goals are to find a safe dose and see if there are any early signs of it helping.

Will I get the actual drug or a placebo?

In this specific study, all participants who are enrolled and receive treatment will receive DS9051b. There is no placebo group.

How long would I be in the study?

The length of time you'd be involved depends on how you respond and the study's design. Your medical team would discuss the expected duration with you.

How to find out more

Daiichi Sankyo Contact for Clinical Trial Information

CTRinfo_us@daiichisankyo.com 908-992-6400 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.