This is a Phase I study designed to evaluate if ASD141 is safe, tolerable, and efficacious in participants with advanced solid tumors.
This is a multicenter, first-in-human (FIH), open-label, non-randomized, dose escalation study of ASD141 to evaluate safety, tolerability, and preliminary anti-tumor activity of ASD141 in subjects with advanced solid tumors. The study includes 8 dose cohorts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Subjects will receive one of 8 dose levels of ASD141.
National Cheng Kung University Hospital
Tainan, Taiwan
RECRUITINGTaipei Medical University Hospital
Taipei, Taiwan
RECRUITINGdose-limiting toxicity
Frequency of dose-limiting toxicity (DLT) at each dose level
Time frame: 28 days
Percentage of participants with adverse events (AEs) and serious AEs (SAEs), vital signs, and abnormal laboratory parameters
Frequency, type, severity, and relationship to ASD141 of adverse events (AEs)
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma Cmax
maximum measured concentration of ASD141 in plasma
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma AUClast
area under the plasma concentration-time curve of ASD141 from hour 0 to last sample with measurable plasma concentrations
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma AUCinfinity
area under the plasma concentration-time curve of ASD141 in plasma over the time interval from 0 extrapolated to infinity
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma t1/2
terminal half-life of ASD141 in plasma
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma tmax
Time of the maximum observed ASD141 concentration
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
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anti-drug antibodies (ADAs)
Presence or absence of anti-drug antibodies (ADAs) against ASD141
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Objective response rate
Percentage of participants with a confirmed CR or PR according to RECIST v1.1
Time frame: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Progressive free survival
The time from first dose of study intervention until the date of objective disease progression or death in the absence of disease progression
Time frame: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Disease control rate
Percentage of participants who have a best objective response of confirmed CR or PR or who have SD lasting for at least a certain time of period after start of treatment
Time frame: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Duration of response
The time from first response according to RECIST v1.1 and iRECIST v1.1 until progression or death in the absence of disease progression
Time frame: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 2 year)