This is a multicenter, open-label, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SNH-118110 administered orally. The study consists of a dose-escalation phase and a dose-expansion phase.
This first-in-human, open-label, multicenter Phase I study is designed to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SNH-118110 administered orally. The study comprises two sequential parts: a dose-escalation phase to identify the maximum tolerated dose (MTD) or maximum administered dose (MAD), followed by a dose-expansion phase to further evaluate safety and anti-tumor activity. The primary endpoints include safety, MTD, and/or MAD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Participants will continue treatment until progression of disease or the end of the study.
The East Hospital Affiliated to Tongji University, Shanghai
Shanghai, Shanghai Municipality, China
Safety evaluation
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Up to approximately 2 years
Maximum tolerated dose (MTD) or maximum administered dose (MAD)
Determination of the MTD or MAD of oral SNH-118110 by the number of participants who experience a dose limiting toxicity (DLT)
Time frame: Cycle 1 (up to 21 days)
The maximum concentration (Cmax)
Cmax of SNH-118110
Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
Time of the maximum concentration (Tmax)
Tmax of SNH-118110
Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t)
AUC0-t of SNH-118110
Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
Elimination half-life (t1/2)
T1/2 of SNH-118110
Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
Objective response rate (ORR)
ORR of SNH-118110 evaluated by investigators per RECIST v1.1
Time frame: Up to approximately 2 years
Disease control rate (DCR)
DCR of SNH-118110 evaluated by investigators per RECIST v1.1
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Time frame: Up to approximately 2 years
Duration of response (DoR)
DoR of SNH-118110 evaluated by investigators per RECIST v1.1
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
PFS of SNH-118110 evaluated by investigators per RECIST v1.1
Time frame: Up to approximately 2 years
Overall survival (OS)
Overall survival (OS)
Time frame: Up to approximately 2 years