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

May 19, 2026 updated by: Daiichi Sankyo

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Toulouse, France, 31100
        • Recruiting
        • Oncopole Claudius Regaud
        • Contact:
          • Principal Investigator
      • Villejuif, France, 94800
        • Not yet recruiting
        • Centre Oscar Lambret
        • Contact:
          • Principal Investigator
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Not yet recruiting
        • Royal Marsden
        • Contact:
          • Principal Investigator
  • United States
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Principal Investigator
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Contact:
          • Principal Investigator
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Brown University
        • Contact:
          • Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DS9051b
Participants with advanced or metastatic adrenocortical carcinoma and metastatic castration-resistant prostate cancer who will receive DS9051b.
Drug: DS9051b
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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).
Baseline up to 50 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Time Frame: Baseline up to 50 months
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.
Baseline up to 50 months
Disease Control by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Time Frame: Baseline up to 50 months
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.
Baseline up to 50 months
Clinical Benefit by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Time Frame: Baseline up to 50 months
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.
Baseline up to 50 months
Duration of Response by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Time Frame: 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
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.
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
Progression-free Survival by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma
Time Frame: 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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS9051-079
  • 2025-521886-28-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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