Phase 1 Trial Testing Oral DS9051b for Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

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.

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