Trials / Recruiting
RecruitingNCT07189403
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)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DS9051b | Administered orally |
Timeline
- Start date
- 2025-11-04
- Primary completion
- 2028-03-01
- Completion
- 2028-03-01
- First posted
- 2025-09-24
- Last updated
- 2026-02-24
Locations
6 sites across 3 countries: United States, France, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07189403. Inclusion in this directory is not an endorsement.