Actively Recruiting
A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Led by Daiichi Sankyo · Updated on 2026-02-24
40
Participants Needed
6
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.
CONDITIONS
Official Title
A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before starting any trial procedures
- Adults 18 years or older at the time of consent
- Histologically confirmed diagnosis of adrenocortical carcinoma or adenocarcinoma of the prostate
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, or 2 if due to cancer pain, assessed within 14 days before treatment
- Adequate organ and bone marrow function based on local lab tests within 14 days before treatment
- For metastatic castration-resistant prostate cancer participants: received at least one line of androgen receptor pathway inhibitor therapy for at least 12 weeks
- For metastatic castration-resistant prostate cancer participants: received at least one line of chemotherapy or are ineligible or refuse chemotherapy
- Documented disease progression by PSA, soft tissue, or bone criteria
You will not qualify if you...
- History of pituitary gland dysfunction
- Active or uncontrolled autoimmune disease needing systemic treatment
- Medical condition requiring more than 5 mg prednisone or 100 mcg fludrocortisone daily
- Active infection or medical condition contraindicating corticosteroids
- Spinal cord compression or active central nervous system metastases needing treatment
- Uncontrolled or significant cardiovascular disease
- History of another primary malignancy except certain treated cancers with no active disease for 3 or more years
- Unresolved toxicities from previous cancer therapy above grade 1 or baseline
- Unable to swallow whole DS9051b tablets or follow dosing schedule
- Known gastrointestinal disease or procedures affecting drug absorption, including use of proton pump inhibitors and antacids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
2
Columbia University
New York, New York, United States, 10032
Not Yet Recruiting
3
Brown University
Providence, Rhode Island, United States, 02903
Actively Recruiting
4
Oncopole Claudius Regaud
Toulouse, France, 31100
Actively Recruiting
5
Centre Oscar Lambret
Villejuif, France, 94800
Not Yet Recruiting
6
Royal Marsden
London, United Kingdom, SW3 6JJ
Not Yet Recruiting
Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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