First-in-Human trial of DS9051b in participants with advanced solid tumors
Research type
Research Study
Full title
A phase 1, First-in-Human, multicenter, open-label trial of DS9051b in participants with advanced or metastatic adrenocortical carcinoma (ACC) and metastatic castration-resistant prostate cancer (mCRPC)
IRAS ID
1012741
Contact name
Bettina Steffens
Contact email
Sponsor organisation
Daiichi Sankyo, Inc.
Eudract number
2025-521886-28
Clinicaltrials.gov Identifier
Research summary
This is a global, multicenter, open-label, FIH, Phase 1 dose escalation study for participants with Advanced or Metastatic Adrenocortical Carcinoma (ACC) and Metastatic Castration-resistant Prostate Cancer (mCRPC). The purpose of the dose escalation part is to determine the maximum tolerated dose/regimen and recommended dose for expansion as well as to establish the safety profile of DS9051b in participants with advanced or metastatic ACC and CRPC. In the dose escalation part, additional participants may be treated in certain dose levels of DS9051b to further explore and determine the safety profile and preliminary efficacy. Approximately 40 eligible participants will be enrolled to receive DS9051b. Participants will continue to receive trial intervention until the time radiographic disease progression has been
documented as assessed per RECIST v1.1 for ACC and PCWG3 criteria for mCRPC by the investigator or other reason for treatment discontinuation has been met. The total duration of trial participation for a participant will be until death, withdrawal of consent, the participant becomes lost to FU, or trial closure, whichever occurs first. Anticipated total duration of the trial is 50 months.REC name
London - Surrey Borders Research Ethics Committee
REC reference
26/LO/0171
Date of REC Opinion
23 Apr 2026
REC opinion
Further Information Favourable Opinion