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Advanced or Metastatic Adrenocortical CarcinomaPhase 1NCT07189403

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

A Phase 1 study testing DS9051b in people with Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer, run by Daiichi Sankyo at 6 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DS9051b
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
6 sitesin 3 countries
Study dates
4 Nov 2025to 1 Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.
  1. 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.
  2. Participants who cannot swallow whole DS9051b tablets and/or follow DS9051b administration schedule at protocol-defined frequency due to some reasons (eg, dysphagia etc).
  3. Known gastrointestinal disease or gastrointestinal procedure that may interfere with absorption of trial intervention including proton pump inhibitors and antacids.

Trial locations and contacts

6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Daiichi Sankyo Contact for Clinical Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

6 sites in 3 countries

United States3 sites, 3 recruiting

  • Columbia University

    New York, New York, 10032

    Principal Investigator

    Recruiting

  • Brown University

    Providence, Rhode Island, 02903

    Principal Investigator

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Principal Investigator

    Recruiting

Other trials in United States

France2 sites, 2 recruiting

  • Oncopole Claudius Regaud

    Toulouse, 31100

    Principal Investigator

    Recruiting

  • Centre Oscar Lambret

    Villejuif, 94800

    Principal Investigator

    Not yet recruiting

Other trials in France

United Kingdom1 site, 1 recruiting

  • Royal Marsden

    London, SW3 6JJ

    Principal Investigator

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 1, First-in-human (FIH), Multicenter, Open-label Trial of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma (ACC) and Metastatic Castration-resistant Prostate Cancer (mCRPC)

This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.

Read the detailed description

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.

Being tested
DS9051b
Keywords
Advanced or metastatic adrenocortical carcinoma, Metastatic castration-resistant prostate cancer
Medical subject headings
Adrenocortical Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS9051bDrug

    Administered orally

Study groups in NCT07189403
Study groupRoleWhat they receive
DS9051bExperimentalParticipants with advanced or metastatic adrenocortical carcinoma and metastatic castration-resistant prostate cancer who will receive DS9051b.
Receives: Drug: DS9051b

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting Dose-limiting Toxicities (DLTs), Treatment-emergent Adverse Events (TEAEs), TEAEs Associated With Treatment Discontinuation, Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) - All Patients

    AEs will be graded using NCI-CTCAE v5.0. A DLT is defined as any TEAE not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc. that occurs during the DLT evaluation period (Day 1 to the end of Cycle 1) and is Grade ≥3 with exceptions as further defined. TEAEs are defined as those AEs with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 30 days after the last dose date of trial intervention).

    Measured: Baseline up to 50 months

Secondary outcomes (5)

  1. Objective Response by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

    Objective response is defined as participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR) as assessed by the investigator per RECIST v1.1 (ACC) or PCWG3 (CRPC). CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: Baseline up to 50 months

  2. Disease Control by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

    Disease control (DC) is defined as participants with a best overall response of confirmed CR or confirmed PR or SD as assessed by the investigator per RECIST v1.1 (ACC) or PCWG3 (CRPC). CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

    Measured: Baseline up to 50 months

  3. Clinical Benefit by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

    Clinical benefit is defined as participants with a best overall response of confirmed CR, confirmed PR, or SD lasting ≥183 days as assessed by the investigator per RECIST v1.1 (ACC) or PCWG3 (CRPC). CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

    Measured: Baseline up to 50 months

  4. Duration of Response by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

    Duration of response (DoR) in a responding participant is defined as the time (in months) from date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression (based on investigator assessment per RECIST v1.1 for ACC patients or PCWG3 for CRPC patients) or death due to any cause. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: From date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression (based on investigator assessment per RECIST v1.1) or death due to any cause, up to 50 months

  5. Progression-free Survival by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma

    Progression-free survival is defined as the time from the date of the first administration of trial intervention to the earliest date of the first objective documentation of radiographic disease progression as assessed by the investigator per RECIST v1.1 or death due to any cause.

    Measured: From the date of the first administration of trial intervention to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to 50 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start4 Nov 2025
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07189403
Sponsor's protocol ID
DS9051-079
Other IDs
2025-521886-28-00, 2025
Status last verified
May 2026
First submitted
16 Sep 2025
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DS9051b in people with Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer, run by Daiichi Sankyo at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daiichi Sankyo Contact for Clinical Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Dose-limiting Toxicities (DLTs), Treatment-emergent Adverse Events (TEAEs), TEAEs Associated With Treatment Discontinuation, Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) - All Patients (time frame: Baseline up to 50 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07189403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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