At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- DS9051b (drug)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- DS9051b — drug: Administered orally
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a new drug called DS9051b in adults with two types of cancer: advanced or spread adrenocortical carcinoma (a cancer of the adrenal glands) and metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to hormone treatment). It is run by Daiichi Sankyo. The aim and how well the drug works are not stated — ask the trial team.
Who can take part
- Adults aged 18 or over who agree in writing to take part
- A confirmed diagnosis of adrenocortical carcinoma or prostate cancer, based on tissue tests
- Being fairly well and able to care for yourself (a performance score of 0 or 1, checked within 14 days before treatment starts; a score of 2 is allowed if caused by cancer pain)
- Healthy enough organs and bone marrow, based on blood tests within 14 days before treatment starts
- For prostate cancer patients: already having had at least one hormone-type treatment (such as abiraterone or enzalutamide) for at least 12 weeks
- For prostate cancer patients: having had at least one course of chemotherapy, being unable to have chemotherapy, or choosing not to have it
- For prostate cancer patients: proof the cancer is getting worse, shown by blood tests, scans or bone changes
Who may not be able to
- Past problems with the pituitary gland
- An active autoimmune disease needing treatment for the whole body
- Needing more than 5 mg of prednisone or 100 micrograms of fludrocortisone a day (or similar steroids) for another condition
- An active infection or other condition that makes steroids unsafe
- Spinal cord compression or cancer spread to the brain or spinal cord that is causing symptoms or needs treatment
- Serious or uncontrolled heart disease
- Another cancer in the last 3 years, apart from some treated skin cancers, some very early cancers, and low-risk prostate cancer
- Side effects from earlier cancer treatment that have not cleared up (except hair loss)
- Being unable to swallow whole tablets or follow the treatment schedule
- Stomach or gut problems or medicines (like antacids) that could stop the drug being absorbed
What taking part involves
- • Taking DS9051b tablets by mouth (swallowed whole)
- • The dose and how often tablets are taken are not stated — ask the trial team
- • What the drug is compared with (if anything) is not stated — ask the trial team
Time commitment: How long the study lasts, how many hospital visits are needed, and what tests are involved are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 40
- Started
- 2025-11-04
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for advanced or metastatic adrenocortical carcinoma
- • Phase1 - 40 participants
- • This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced or metastatic adrenocortical carcinoma
Where?
- • London - Royal Marsden
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.
More detail
The purpose of the dose escalation part is to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE), as well as to establish the safety profile of DS9051b in participants with advanced or metastatic ACC and mCRPC.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ active intervention
What the study is looking for
- ✓General Inclusion Criteria for All Participants
- ✓Sign and date the main ICF, prior to the start of any trial-specific procedures.
- ✓Adults ≥18 years of age at the time the ICF is signed (Follow local regulatory requirements if the legal age of...
- ✓confirmed by a biopsy diagnosis of ACC or adenocarcinoma of the prostate
- ✓ECOG PS of 0 or 1 assessed no more than 14 days prior to C1D1. (ECOG PS of 2 due to cancer pain is acceptable)
See the full criteria
Where Is This Study? (1 UK site)
Royal Marsden
London SW3 6JJ, United Kingdom
How to Get in Touch
Daiichi Sankyo Contact for Clinical Trial Information
Sponsor contactCONTACT
