Solid tumors
Conditions
Interventions
investigational material(s)
Generic name etc : SCC244
INN of investigational material : glumetinib
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Oral 2
Sponsors
Shanghai Haihe Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Can fully understand and sign informed consent form (ICF) voluntarily 2.Male and female patients 18-80 (inclusive) on the day of signing informed consent. However, in case a subject is younger than 20 years old, written informed consent will be obtained from both a subject and a legal representative and the written informed consent will be re-obtained from the above subject when he or she will be 20 years old. 3.Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapies or for which there is no effective standard treatment. 4.At least one measurable or non-measurable lesion as per RECIST version1.1. 5.ECOG Performance Status (PS): 0-1. 6.Adequate bone marrow reserve, renal and liver function: -Absolute neutrophil count >= 1.5x109/L; -Hemoglobin >= 9 g/dL; -Platelet count >= 75 x 109/L; -Serum total bilirubin 50 mL/min (calculated with Cockcroft-Gault formula). -International normalized ratio (INR) <= 1.5 or activated partial thromboplastin time (aPTT) <= 1.5xULN.
Exclusion criteria
Exclusion criteria: 1.Patients who have already a confirmed negative test for MET mutation (tumor testing is not required for this study) 2.Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid. (Note: Patients with controlled CNS metastasis can participate in the trial. Before entering the study, patients should have finished radiotherapy, or have received operation for CNS tumor metastasis at least two weeks before. 3.Patients neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new problem is found during CNS imaging examinations. If patients need to use steroids to treat CNS metastasis, the therapeutic dose of steroid should be stable for => 3 months at least two weeks prior to entering the study.) 4.Evidence of other malignancies (except for non-melanoma skin cancer, in situ breast cancer or in situ cervical carcinoma and superficial bladder cancer that have been effectively controlled in the last 5 years). 4.Patients' life expectancy 450 ms (male) or QTcF>470 ms (female); or there are risk factors of torsade de pointes, such as clinically significant hypokalemia, family history of long QT syndrome or arrhythmia at the investigator's discretion (e.g. pre-excitation syndrome); -Clinically uncontrolled hypertension (after standard antihypertensive treatment, systolic blood pressure =>140 mmHg and/or diastolic blood pressure => 90 mmHg); 6.Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2prior platinum-therapy related neuropathy. 7.Active and clinically significant hepatitis including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) infection. The following patients will not be enrolled: 1)Confirmed HIV antibody positive. 2)Anti-HCV antibody positive and HCV-RNA positive. (In case of positive for Anti-HCV antibody, the patients with negative HCV-RNA can be enrolled.) 3)Patients with -Hepatitis B surface antigent (HBsAg) positive, or -Anti-Hepatitis B core antibody (HBcAb) positive, or -Anti-Hepatitis B surface antibody (HBsAb) positive and HBV DNA positive. (In case of positive for anti-HBs antibody, the patients with negative HBV DNA can be enrolled.) 8.History of hypersensitivity to active or inactive excipients of SCC244 or drugs with a similar chemical structure or class to SCC244. 9.Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, or hormone therapy) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the investigational product. 10.Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks. 11.Major surgery or had significant trau
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics 1.Number and proportion of patients who experienced at least 1 DLT during the first 28-day of continuous dosing period; incidence, duration and severity of AEs, physical examination, laboratory data, vital signs and ECG changes. 2.Pharmacokinetic parameters of SCC244 include but are not limited to: Cmax, tmax, AUC0-t, AUC0-inf, t1/2, CL/F and Vz/F, and its metabolites. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1.Object Response Rate (ORR), Duration of Response (DOR), Disease Control Rate (DCR), Time to Response (TTR), Progression-Free Survival (PFS), 6-month PFS. | — |
Countries
Japan
Outcome results
None listed