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This is a phase 1, open-label, dose-escalation trial of HS-10241 as monotherapy in subjects with solid tumors. HS-10241 will be administered orally once daily.
Full description
Recently, c-Met has become an important target of intensive research in search of specific inhibitors as potential new therapies for cancers driven by c-Met activation. HS-10241 is a potent and selective small molecule c-Met kinase inhibitor for both enzyme and c-Met phosphorylation in the cell. Consistent with its potent enzyme and cell activity, HS-10241 was found to inhibit cell growth in vitro against tumors with c-Met gene amplification or c-Met overexpression. On the basis of these findings, the current trial will be conducted in participants with advanced solid tumors for whom standard treatment is not currently available.
This study consists of 2 phases. In the dose-escalation phase, up to 5 dose levels of HS-10241 (100 mg/day, 200 mg/day, 340 mg/day, 500 mg/day, and 700 mg/day) will be investigated with a sequential "3+3" design (3 or 6 participants in every dose level). Participants will have a single-dose pharmacokinetic (PK) run-in period (7 days). Following the first dose, participants will enter a 1 week treatment-free period to evaluate safety and single-dose PK. If no dose-limiting toxicities (DLTs) are observed during the 1-week period, HS-10241 administration will resume at the same dose level.
In the expansion phase, up to 12 additional participants will be enrolled at the MTD. Anti-tumor effects will be assessed every 2 cycles (4 weeks=1 cycle) by using RECIST version 1.1 criteria.
Enrollment
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Inclusion criteria
At least 18 years of age
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 (ICF).
Histologically or cytologically confirmed advanced or metastatic solid tumor for which standard therapy does not exist, has failed, or has been refused.
Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (except alopecia)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 3 months
Acceptable liver function defined below:
Acceptable renal function defined below:
Acceptable coagulation status defined below:
Acceptable hematologic status (without hematologic supports including hematopoietic factor, blood transfusion) defined below:
No clinically significant abnormalities in urinalysis
All participants must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an intrauterine device) with their partner from entry into the trial through 6 months after the last dose.
Exclusion criteria
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Masking
7 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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