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A Study of DS9051b for Adrenocortical Carcinoma and Prostate Cancer

This study is testing a new oral medicine called DS9051b for people with advanced or metastatic adrenocortical carcinoma (a rare cancer of the adrenal glands) or metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to hormone therapy). The main goals are to understand the safety of DS9051b, find the right dose, and see if it shows any early signs of helping to treat these cancers. You might be able to join if you are an adult aged 18 or older with a confirmed diagnosis of one of these cancers. The study will look at side effects and how well the medicine is tolerated over a period of up to 50 months.

Study design
This is an interventional study planning to enroll 40 participants. It is designed to find the maximum tolerated dose and recommended dose of DS9051b.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects from the start of the study up to 50 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07189403

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Daiichi Sankyo
~40 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:DS9051b

At a glance

Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Baseline up to 50 months

Conditions

Advanced or Metastatic Adrenocortical Carcinoma
Metastatic Castration-resistant Prostate Cancer

Explore related trials

Adrenal Cortical CarcinomaProstate Carcinoma

Where it's being run

6 sites across 5 states
France2
Florida1
New York1
Rhode Island1
United Kingdom1

Who to contact

Daiichi Sankyo Contact for Clinical Trial Information
[email protected]
908-992-6400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

What this trial measures

  • 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 PatientsBaseline 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).