Phase I First-in-Human Study of DS9051b in Patients with Advanced/Metastatic Adrenocortical Carcinoma and Metastatic Castration‑Resistant Prostate Cancer

The trial enrolled 25 participants diagnosed with Advanced or Metastatic Adrenocortical Carcinoma (ACC) or metastatic castration‑resistant prostate cancer; both male and female adults were eligible, with age range codes “3” and “4” indicating adult age categories (exact ages not disclosed). All subjects were classified as patients and the study included vulnerable individuals as defined by regulatory criteria. Inclusion required a confirmed diagnosis of the specified malignancies; exclusion criteria were not detailed, and no specific dietary, physical activity, or habit restrictions were reported.

The study is a first‑in‑human phase 1 trial evaluating the safety, tolerability, and pharmacokinetic profile of DS9051b in adults with advanced solid tumors, including advanced or metastatic adrenocortical carcinoma and metastatic castration‑resistant prostate cancer; recruitment is scheduled to begin in January 2026 and continue until March 2028. After an initial screening visit to confirm eligibility, participants receive a single or multiple ascending dose of the investigational product and return for regular follow‑up assessments (clinical examinations, laboratory tests, and imaging) at predefined intervals to monitor adverse events and drug exposure. The overall participant involvement extends from the first dose until the scheduled end-of-study visit, which occurs after the final safety and efficacy evaluations are completed or upon discontinuation. Early discontinuation may occur if predefined criteria are met, such as clinically significant toxicity, disease progression that precludes further assessment, withdrawal of consent, or a decision by the investigator that continuation is not in the participant’s best interest. The trial design incorporates systematic data collection at each visit to support a comprehensive safety and dose‑escalation analysis.

Efficacy assessments will be performed in accordance with the study protocol for patients with advanced or metastatic adrenocortical carcinoma and metastatic castration‑resistant prostate cancer.