RecruitingPhase 1NCT07189403

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

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)


Sponsor

Daiichi Sankyo

Enrollment

40 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called DS9051b for two types of cancer: adrenocortical carcinoma (a rare cancer of the adrenal glands) and prostate cancer that has spread despite hormone therapy (called metastatic castration-resistant prostate cancer). **You may be eligible if...** - You are 18 or older - You have confirmed adrenocortical carcinoma or prostate cancer that has spread and stopped responding to hormone therapy - For prostate cancer: you have received at least one hormone-blocking drug and at least one round of chemotherapy (or are not able to have chemotherapy) - Your disease is progressing based on PSA levels, imaging, or bone scans - You are well enough to participate (ECOG 0 or 1; ECOG 2 acceptable if pain is the reason) **You may NOT be eligible if...** - You have a history of pituitary gland problems - You have an active autoimmune disease requiring treatment - You require high-dose steroids for a non-cancer condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDS9051b

Administered orally


Locations(6)

Florida Cancer Specialists

Sarasota, Florida, United States

Columbia University

New York, New York, United States

Brown University

Providence, Rhode Island, United States

Oncopole Claudius Regaud

Toulouse, France

Centre Oscar Lambret

Villejuif, France

Royal Marsden

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07189403


Related Trials