Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase1

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

Sponsor: Daiichi Sankyo

NCT ID: NCT07189403

View on ClinicalTrials.gov ↗

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.

Advanced or Metastatic Adrenocortical CarcinomaMetastatic Castration-resistant Prostate Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

metPSA

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
General Inclusion Criteria for All Participants 1. Sign and date the main ICF, prior to the start of any trial-specific procedures. 2. Adults ≥18 years of age at the time the ICF is signed (Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old) 3. Histologically confirmed diagnosis of ACC or adenocarcinoma of the prostate 4. 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) 5. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to C1D1 as defined below. Organ and bone marrow function criteria must also be met when laboratory tests are repeated within 3 days of initiation of trial intervention as appropriate. Additional Inclusion Criteria for Participants with mCRPC 6. Treatment with at least 1 line (or more) of ARPI therapy for CSPC or in CRPC for a minimum of 12 weeks (eg, abiraterone, enzalutamide, darolutamide, apalutamide). 7. Treatment with at least 1 line (or more) of chemotherapy, having ineligibility for chemotherapy or refusal of chemotherapy. 8. Documented disease progression by one or more of the following criteria: * PSA progression as defined by PCWG3 criteria. * Soft tissue disease progression as defined by RECIST 1.1 criteria. * Bone disease progression as defined by Prostate Cancer Working Group 3 criteria. An individual who meets any of the following criteria will be excluded from participation in this trial: 1. History of pituitary gland dysfunction. 2. Active or uncontrolled autoimmune disease requiring systemic treatment. 3. Any medical condition (other than the cancer disease) requiring a dose of concurrent systemic corticosteroid treatment greater than 5 mg of prednisone and/or 100 μg of fludrocortisone per day (or equivalent). 4. Active infection or other medical conditions that would make corticosteroids contraindicated. 5. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated, clinically progressive, symptomatic, or requiring systemic therapy with corticosteroids or anticonvulsants or local therapy (ie, radiotherapy) to control associated symptoms. 6. Uncontrolled or significant cardiovascular disease. 7. History of another primary malignancy (beyond the indication\[s\] under study) except for: * Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of trial intervention and of low potential risk for recurrence. * Non-melanoma skin cancer, lentigo maligna, or lentigo maligna melanoma treated with curative intent and without evidence of disease. * Carcinoma in situ treated with curative intent and without evidence of disease. * Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who, in the opinion of the investigator, are not deemed to require active intervention. 8. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, Grade ≤1 or baseline. 9. Participants who cannot swallow whole DS9051b tablets and/or follow DS9051b administration schedule at protocol-defined frequency due to some reasons (eg, dysphagia etc). 10. Known gastrointestinal disease or gastrointestinal procedure that may interfere with absorption of trial intervention including proton pump inhibitors and antacids.

Where Is This Study? (1 UK site)

Royal Marsden

London SW3 6JJ, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Daiichi Sankyo Contact for Clinical Trial Information

Sponsor contact

CONTACT

908-992-6400 CTRinfo_us@daiichisankyo.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05