This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Administered orally
Florida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGColumbia University
New York, New York, United States
NOT_YET_RECRUITINGBrown University
Providence, Rhode Island, United States
Number of Participants Reporting Dose-limiting Toxicities (DLTs), Treatment-emergent Adverse Events (TEAEs), TEAEs Associated With Treatment Discontinuation, Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) - All Patients
AEs will be graded using NCI-CTCAE v5.0. A DLT is defined as any TEAE not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc. that occurs during the DLT evaluation period (Day 1 to the end of Cycle 1) and is Grade ≥3 with exceptions as further defined. TEAEs are defined as those AEs with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 30 days after the last dose date of trial intervention).
Time frame: Baseline up to 50 months
Objective Response by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Objective response is defined as participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR) as assessed by the investigator per RECIST v1.1 (ACC) or PCWG3 (CRPC). CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time frame: Baseline up to 50 months
Disease Control by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Disease control (DC) is defined as participants with a best overall response of confirmed CR or confirmed PR or SD as assessed by the investigator per RECIST v1.1 (ACC) or PCWG3 (CRPC). CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Time frame: Baseline up to 50 months
Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
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IUCT Oncopole
Toulouse, France
NOT_YET_RECRUITINGCentre Oscar Lambret
Villejuif, France
NOT_YET_RECRUITINGRoyal Marsden
London, United Kingdom
NOT_YET_RECRUITINGClinical Benefit by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Clinical benefit is defined as participants with a best overall response of confirmed CR, confirmed PR, or SD lasting ≥183 days as assessed by the investigator per RECIST v1.1 (ACC) or PCWG3 (CRPC). CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Time frame: Baseline up to 50 months
Duration of Response by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Duration of response (DoR) in a responding participant is defined as the time (in months) from date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression (based on investigator assessment per RECIST v1.1 for ACC patients or PCWG3 for CRPC patients) or death due to any cause. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time frame: From date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression (based on investigator assessment per RECIST v1.1) or death due to any cause, up to 50 months
Progression-free Survival by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma
Progression-free survival is defined as the time from the date of the first administration of trial intervention to the earliest date of the first objective documentation of radiographic disease progression as assessed by the investigator per RECIST v1.1 or death due to any cause.
Time frame: From the date of the first administration of trial intervention to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to 50 months