This study is designed to assess the safety, tolerability, and efficacy of DS3610a, given as a single agent to participants with advanced or metastatic solid tumors.
This is a dose escalation study for participants with advanced or metastatic solid tumors. The primary objective of the study is to determine the Recommended Dose for Expansion (RDE), and to evaluate the safety, tolerability, PK, and preliminary efficacy of DS3610a in solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Participants will receive DS3610a at the target dose. Treatment will continue until radiographic disease progression, as determined by the investigator, or until another reason for discontinuation of trial intervention occurs.
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITINGOncopole Claudius Regaud
Toulouse, France
RECRUITINGNational Cancer Center Hospital
Chūōku, Japan
RECRUITINGDose Limiting Toxicities
Time frame: From first dose, up to approximately 24 months
Area Under the Blood Concentration-time Curve During Dosing Interval
Area Under the Blood Concentration-time Curve During Dosing Interval (AUCtau) will be used to asses PK parameters
Time frame: From baseline to postbaseline, up to approximately 36 months
Antidrug Antibody Prevalence
The percentage of participants who are Antidrug Antibody positive at any point in time.
Time frame: From baseline to postbaseline, up to approximately 36 months
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National Cancer Center Hospital East
Kashiwa, Japan
RECRUITING