A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of SCC244 in Japanese Patients with Advanced Solid Tumors

Shanghai Haihe Pharmaceutical Co., Ltd.0 sites6 target enrollmentMarch 13, 2020

ConditionsSolid tumors

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Solid tumors
Sponsor: Shanghai Haihe Pharmaceutical Co., Ltd.
Enrollment: 6
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 13, 2020

End Date

May 31, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Shanghai Haihe Pharmaceutical Co., Ltd.

Eligibility 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 \<\= upper limit of normal (ULN);

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 \< 3 months at the investigator's discretion.
•5\.Subjects with clinically significant cardiovascular disease, including:
•\-NYHA Class II or higher congestive heart failure:
•\-Severe arrhythmia requiring drug therapy;
•\-Acute myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral artery bypass graft received within 6 months prior to the first dose;
•\-Left ventricular ejection fraction (LVEF) \< 50%;
•\-QTcF\>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);