A Trial of C-met Kinase Inhibitor HS-10241 in Subjects With Advanced Solid Tumours

  • STATUS
    Recruiting
  • End date
    Nov 21, 2021
  • participants needed
    50
  • sponsor
    Jiangsu Hansoh Pharmaceutical Co., Ltd.
Updated on 21 January 2021
platelet count
renal function
cancer
kinase inhibitor
metastasis
neutrophil count
liver metastasis
advanced cancer
cancer treatment
solid tumor
metastatic solid tumor

Summary

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.

Details
Condition Carcinoma, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, Solid Tumor, Adult, carcinomas, Solid Tumor, Adult
Treatment HS-10241
Clinical Study IdentifierNCT02977364
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Solid Tumor, Adult or Carcinoma?
Do you have any of these conditions: carcinomas or Solid Tumor, Adult or Vulvar Dysplasia and Carcinoma or Carcinoma or Advanced Malignancies?
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 FISH4 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
Absolute neutrophil count (ANC) 1500/L
Platelet count 100000/L
Hemoglobin 9.0 g/dL
Acceptable liver function defined below
Total bilirubin 2 times upper limit of normal range (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 times ULN; however, 5 times ULN in a subject who has liver metastases
Acceptable renal function defined below
Serum creatinine 1.5 times ULN or calculated creatinine clearance (by the Cockcroft-Gault formula) 60 mL/minutes
Acceptable coagulation status defined below
Prothrombin time < 1.5 times ULN
Partial thrombin time < 1.5 times UL
HIV Ag/Ab(-)
HCV Ab(-);or HCV Ab(+) but HCV RNA(-)
HBsAg-and HBcAb-in dose escalation phaseHBV DNA<1103copies/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

Treatment with other c-MET TKI( specific target or multi-target)
Anti-cancer treatment with radiation therapynot including non target lesions receiving palliative radiotherapy, chemotherapy,hormonotherapy or surgerysmall surgery, including the implantation of external equipment or fine needle aspiration, at least 7 days; diagnostic or palliative surgery, at least 14 days within 4 weeks (6 weeks for nitrosoureas or Mitomycin C)prior to trial entry
Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease
Symptomatic brain metastases or unstable brain metastases (notes: Patients with asymptomatic brain metastases previously treated for the study, but must be kept stable for at least 4 weeks and receive a stable dose of the drug)
Obvious neurological and mental disorder
Other previous or concomitant tumors (except for the effective treatment of melanoma, cervical carcinoma in situ, ductal carcinoma in situ or malignant tumor after effective treatment, remission 3 years and considered to have been cured)
Active, uncontrolled bacterial, fungal infections, requiring systemic therapy
Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within 0.5 year of trial entry)
History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
Participation in an investigational drug or device trial within 4 weeks prior to the trial entry
Anti-cancer treatment with radiation therapy, chemotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry
Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery
Taking a medication that is a moderate or strong inhibitor or inducer of CYP2C9; taking a medication that prolongs QT interval and has a risk of Torsades de Pointes
Pregnant (positive serum beta human chorionic gonadotropin [-HCG] test at Screening) or is currently breast-feeding, their partner anticipates becoming pregnant/impregnating during the trial or within 6 months after receiving the last dose of trial treatment
Known drug abuse or alcohol abuse
Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial
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