Actively Recruiting
A Phase 1, First-in-human, Open-label Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Led by Daiichi Sankyo · Updated on 2026-05-22
40
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and early signs of effectiveness of DS9051b in adults with advanced or metastatic adrenocortical carcinoma (ACC) and metastatic castration-resistant prostate cancer (mCRPC). This first-in-human phase 1 trial aims to find the highest dose that can be given safely and to understand how the drug behaves in these patients. The study is sponsored by Daiichi Sankyo and focuses on these two serious cancer types. Participants will receive DS9051b orally as part of a dose escalation process to determine the maximum tolerated dose and the best dose for further study. The trial is open-label and involves multiple centers. All participants receive the experimental drug, and there are no placebo or comparator groups. The treatment period can last up to 50 months, during which various doses will be tested and adjusted based on safety and tolerability. Throughout the study, participants will be closely monitored for side effects, including dose-limiting toxicities and serious adverse events. Researchers will assess treatment responses using imaging and clinical evaluations, documenting disease control and progression. Visits include laboratory tests, physical exams, and assessments of cancer status. The study will also measure progression-free survival and duration of response over the course of up to 50 months, with ongoing safety follow-up during this period.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Signed informed consent form before starting trial procedures
- Histologically confirmed diagnosis of adrenocortical carcinoma or adenocarcinoma of the prostate
- ECOG performance status of 0 or 1, or 2 if due to cancer pain, assessed within 14 days before treatment
- Adequate organ and bone marrow function within 14 days before treatment
- For metastatic castration-resistant prostate cancer: received at least one line of androgen receptor pathway inhibitor therapy for a minimum of 12 weeks
- For metastatic castration-resistant prostate cancer: received at least one line of chemotherapy or are ineligible or refuse chemotherapy
- Documented disease progression by specified clinical criteria
You will not qualify if you...
- History of pituitary gland dysfunction
- Active or uncontrolled autoimmune disease requiring systemic treatment
- Medical conditions requiring systemic corticosteroids above specified doses
- Active infection or contraindications to corticosteroids
- Spinal cord compression or active central nervous system metastases needing treatment
- Uncontrolled or significant cardiovascular disease
- History of other primary malignancies except certain treated cancers with no active disease
- Unresolved toxicities from previous cancer therapies above specified grade
- Inability to swallow whole DS9051b tablets or follow administration schedule
- Known gastrointestinal diseases or procedures interfering with drug absorption including use of proton pump inhibitors or antacids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 50 months
Participants receive the study drug DS9051b orally to assess the maximum tolerated dose, safety profile, and effectiveness in advanced or metastatic cancer.
Repeated visits during treatment for safety and response assessments
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
Actively 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
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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