The purpose of this study is to assess the safety and tolerability of DS-1055a in participants with relapsed or refractory locally advanced or metastatic solid tumors for which no standard treatment is available.
This Phase 1, open-label, non-randomized, dose escalation, first-in-human study will assess the safety and tolerability of DS-1055a, determine the maximum tolerated dose of DS-1055a, pharmacokinetic (PK) properties of DS-1055a, and the incidence of anti-drug antibodies (ADAs) against DS-1055a and other antibodies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Administered as an intravenous infusion on Day 1 of every 21-day cycle following low dose administration(s) in priming dose period. Infusion duration: 180 minutes for the first infusion, and if no infusion-related reaction, 120 minutes for subsequent infusions
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States
Princess Margaret Cancer Center
Toronto, Ontario, Canada
National Cancer Center Hospital
Chūōku, Japan
Number of participants with dose-limiting toxicities
A dose-limiting toxicity (DLT) is defined as any treatment-emergent adverse event (TEAE) that occurs during the DLT evaluation period (21 days), excluding toxicities clearly related to disease progression or intercurrent illness or to concomitant medications or to concomitant procedures and is Grade 3 or above according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0, with certain specified exceptions.
Time frame: 21 days of Cycle 1
Number of participants with adverse events
Adverse events were assessed using National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
Time frame: Baseline up to approximately 3 years
Maximum Plasma Concentration (Cmax)
Time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)
Area Under the Plasma Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau)
Time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)
Minimum Observed Concentration (Ctrough)
Time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)
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National Cancer Center Hospital East
Kashiwa, Japan
Cancer Institute Hospital of JFCR
Kōtoku, Japan
The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies
Time frame: From pre-treatment to follow-up visit (within approximately 2 years)