The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors.
The study consists of a dose-escalation phase that will evaluate 6 dosing schedules of hSTC810. The first cohort will be single participant cohort. Subsequent escalation cohorts will use a standard 3+3 design, with the ability to backfill up to an additional 6 patients in each dose cohort.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
hSTC810 will be administered as an intravenous infusion (IV)
Yale Cancer Center
New Haven, Connecticut, United States
Mount Sinai Hospital
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Korea University Anam Hospital
Seoul, South Korea
Incidence of DLTs
Number and percentages of subjects with DLTs
Time frame: 4 weeks
Incidence of AEs, SAEs, and abnormalities in Lab
Number and percentages of subjects with Adverse Event, serious AEs, and abnormalities in lab parameters
Time frame: from signing ICF to 90 days after last dose
Peak plasma concentration (Cmax)
Maximum plasma concentration of hSTC810 to evaluate the PK parameters
Time frame: Up to 2 years
Minimum plasma concentration (Cmin)
Minimum blood plasma concentration of hSTC810 to evaluate the PK parameters
Time frame: Up to 2 years
Time to maximum plasma concentration (Tmax)
Time to reach Cmax of hSTC810 to evaluate the PK parameters.
Time frame: Up to 2 years
Area under the plasma concentration - time curve (AUC0-t)
AUC up to the last measurable concentration of hSTC810 to evaluate the PK parameters
Time frame: Up to 2 years
Incidence of ADA
Number and percentages of subjects with positive ADAs
Time frame: Up to 2 years
Objective response rate (ORR)
Percentage of participants with confirmed CR and confirmed PR determined by RECIST v1.1 and iRECIST
Time frame: Up to 2 years
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Yonsei University Severance Hospital
Seoul, South Korea
Best overall response (BOR)
the best response designation as determined by RECIST and iRECIST. The BOR will be categorized as a CR, PR, SD, or PD
Time frame: Up to 2 years
Clinical Benefit rate (CBR)
Percentage of Participants With confirmed CR, confirmed PR or SD with a duration of at least 6 months determined by RECIST v1.1 and iRECIST
Time frame: Up to 2 years
Duration of response (DoR)
Time from initial response of confirmed CR or PR to disease progression or death determined by RECIST v1.1 and iRECIST
Time frame: Up to 2 years
Progression free survival (PFS)
The period from the first dose to the documented disease progression or death determined by RECIST v1.1 or iRECIST
Time frame: Up to 2 years
Overall survival (OS)
The period from first dose to the day of death from any cause.
Time frame: Up to 2 years