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)
Daiichi Sankyo
Summary
This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
General Inclusion Criteria for All Participants 1. Sign and date the main ICF, prior to the start of any trial-specific procedures. 2. Adults ≥18 years of age at the time the ICF is signed (Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old) 3. Histologically confirmed diagnosis of ACC or adenocarcinoma of the prostate 4. ECOG PS of 0 or 1 assessed no more than 14 days prior to C1D1. (ECOG PS of 2 due to cancer pain is acceptable) 5. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to C1D1…
Interventions
- DrugDS9051b
Administered orally
Locations (6)
- Florida Cancer SpecialistsSarasota, Florida
- Columbia UniversityNew York, New York
- Brown UniversityProvidence, Rhode Island
- Oncopole Claudius RegaudToulouse
- Centre Oscar LambretVillejuif
- Royal MarsdenLondon