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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10241 100mg | Experimental | HS-10241 100mg daily |
|
| HS-10241 200mg | Experimental | HS-10241 200mg daily |
|
| HS-10241 400mg | Experimental | HS-10241 400mg daily |
|
| HS-10241 600mg | Experimental | HS-10241 600mg daily |
|
| HS-10241 800mg | Experimental | HS-10241 800mg daily |
|
| HS-10241 1000mg | Experimental | HS-10241 1000mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10241 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD of HS-10241 based on the incidence of dose limiting toxicities | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | 12 months | |
| Max concentration (Cmax) of HS-10241 | 4 weeks | |
| Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi, MD | Contact | 86(10)87788293 | syuankaipumc@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 8 weeks |
| Incidence and intensity of Adverse Events according to Common Toxicity Criteria for AEs (CTCAE version 4.0) | 8 weeks |
| Area under the plasma concentration versus time curve (AUC) of HS-10241 | 4 weeks |
| Elimination half-life(T1/2) of HS-10241 | 4 weeks |