The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics, and determine the maximum tolerated dose of ZSP1241 in participants with hepatocellular carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
ZSP1241 tablets for oral administration.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGSafety and tolerability of ZSP1241 in single dose ascending (SAD) and multiple dose ascending (MAD) as measured by assessment of maximum tolerated dose (MTD), dose limiting toxicity (DLT) and treatment emergent adverse events (TEAEs)
Participant with TEAEs assessed by CTCAE V5.0
Time frame: At Day 7 for SAD Part and At day 28 after for MAD part
Time to progression (TTP).
Time frame: Screening, Day 28 of Cycle 1 (28 days), then every 6 weeks for hepatocellular carcinoma or 8 weeks for other advanced solid tumors, until disease progression or discontinuation from study (up to 18 months).
Overall response rate (ORR).
Time frame: Screening, Day 28 of Cycle 1 (28 days), then every 6 weeks for hepatocellular carcinoma or 8 weeks for other advanced solid tumors, until disease progression or discontinuation from study (up to 18 months).
Cmax of ZSP1241
Defined as maximum observed plasma concentration
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
Tmax of ZSP1241
Defined as time to maximum plasma concentration
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
Cmin of ZSP1241
Defined as minimum observed plasma concentration during the dosing interval
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
AUC0-t of ZSP1241
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration
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Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
t½ of ZSP1241
Defined as the apparent plasma terminal phase disposition half-life
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
Cl/F of ZSP1241
Defined as oral dose clearance
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.