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To investigate safety, tolerability and pharmacokinetics of C-met Kinase Inhibitor HS-10241 in Subjects With Advanced Solid Tumours that are not eligible for conventional or intensive treatment. The dose of HS-10241 will be escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of HS-10241 in advanced cancer patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of HS-10241 will be observed in advanced cancer patients. To determine the recommended dosage regimen for phase II.
Enrollment
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Volunteers
Inclusion criteria
Histologically confirmed advanced or metastatic solid tumor for which standard therapy does not exist, has failed, or has been refused.
c-MET positive patients preferred in dose escalation phase; c-MET of patients must fulfill ICH++~+++ or FISH≥4 times in dose expansion phase.
Confirmed that there are at least 1 can be measured in accordance with the standard RECIST1.1 by CT or MRI.
18 ~65 years of age.
ECOG performance status of 0~1.
Life expectancy of at least 3 months.
Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (except alopecia).
Acceptable hematologic status (without hematologic supports including hematopoietic factor, blood transfusion) defined below:
Acceptable liver function defined below:
Acceptable renal function defined below:
Acceptable coagulation status defined below:
HIV Ag/Ab(-).
HCV Ab(-);or HCV Ab(+) but HCV RNA(-).
HBsAg(-)and HBcAb(-)in dose escalation phase;HBV DNA<1×103copies/ml if HBsAg(+)or HBcAb(+)in dose expansion phase.
Ability to understand the purposes and risks of the trial and his/her informed consent using the human research ethics committee (HREC) approved informed consent form was obtained before the entering the trial.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
50 participants in 6 patient groups
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Central trial contact
Yuankai Shi, MD
Data sourced from clinicaltrials.gov
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