This is an open-label, sequential dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of DS-8895a in Japanese subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Osaka University Hospital
Suita, Osaka, Japan
number of participants experiencing dose limiting toxicities
to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events
Time frame: day 1 through day 28
number of participants experiencing clinical or laboratory adverse events
to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events
Time frame: from start of treatment to end of treatment, on expected average 12 weeks
serum pharmacokinetics of DS-8895a
pharmacokinetics (Area Under the Curve-AUC, Terminal Elimination half-life-t1/2, Total Body Clearance) of DS-8895a in Japanese subjects with advanced solid tumors, and also to investigate the recommended dose of DS-8895a for subsequent clinical studies
Time frame: Cycle 1 - days 1, 2, 4, 8 and 15; Cycle 2-days 1, 2, 4, 8 and 15; Cycle 3 and on- days 1; end of study; 45 days post last dose
level of anti-DS-8895a (HAHA) antibody
Human anti-human antibody (HAHA) profile for DS-8895a \[Time Frame: Cycle 1 - days 1, and 15; Cycle 2 and on - days 1; end of study; 45 days post last dose\] The presence of HAHA (anti-DS-8895a neutralizing antibody) in serum will be assessed"
Time frame: Cycle 1 days 1 and 15; Cycle 2 day 1; end of study; 45 days post-last-dose
disease control rate
proportion of subjects with the best overall response of stable disease or better will be measured every 6 weeks until study drug discontinued.
Time frame: every 6 weeks
pharmacodynamic effects in blood
effects on blood will be determined at day 1 and 2 of each cycle
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Time frame: day 1 and 2
pharmacodynamic effects in tumors
effects on tumor cells will be determined at baseline and day 1 of cycle 2
Time frame: baseline and day 1 of cycle 2
objective response rate
sum of complete response and partial response rates measured every 6 weeks until study drug discontinuation
Time frame: every 6 weeks