An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Intravenous infusion
Shizuoka Cancer Center /ID# 166940
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 166939
Chuo-ku, Tokyo, Japan
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
AUC (0-t) is defined as area under the concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.
Time frame: Up to 24 months
Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399
MTD/MAD is defined as the highest dose level at which less than 2 of 6 (or \< 33% if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Time frame: Up to 21 days
Terminal elimination half life (t1/2)
Terminal elimination half life (t1/2)
Time frame: Up to 24 months
Maximum Observed Concentration (Cmax)
Maximum observed concentration (Cmax)
Time frame: Up to 24 months
Time to Cmax (Tmax)
Time to Cmax (Tmax)
Time frame: Up to 24 months
Progression-Free Survival (PFS) Time
PFS time is defined as the time from the participant's first dose of ABBV-399 to either the participant's disease progression or death, whichever occurs first.
Time frame: Up to 24 months
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants with a confirmed partial or complete response to the treatment. Evaluation of tumor response is based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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Time frame: Up to 24 months
Duration of response (DOR)
DOR is defined as the time from the participant's initial objective response to study drug therapy to disease progression or death, whichever occurs first.
Time frame: Up to 24 months