Phase I Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of HM781-36B
- 1) Histologically or cytologically confirmed advanced solid tumor 2) Patients who
have experienced progressive disease despite of conventional anticancer therapy.
Patients who cannot expect effective treatment or prolonged survival with
conventional anticancer therapy 3) Previous chemotherapy, radiotherapy and surgical
operation are allowed if they are discontinued for at least 4 weeks prior to D0 and
all adverse events are resolved 4) Aged ≥19 5) Eastern Cooperative Oncology Group
(ECOG) performance score of less than or equal to 2 6) A life expectancy greater than
12 weeks 7) Adequate bone marrow (WBC≥4,000/mm3 platelet≥100000/mm3,
hemoglobin≥9.0g/dl and ANC≥ 1500/mm3, renal (Creatinine≤1.5mg/dl) and liver function
(AST/ALT/ALP ≤ 3 x upper limit of normal and total bilirubin≤2mg/dl) and no abnormal
heart and lung function However, AST/ALT/ALP ≤ 5 x upper limit of normal for patients
with liver metastases and ALP level ≤ 5 x upper limit of normal for patients with
bone metastases are allowed 8)Subjects must provide written informed consent prior to
performance of study specific procedures or assessments, and must be willing to
comply with treatment and follow up assessments and procedures
- 1) Patients with hematopoietic malignancies,uncontrolled infection, ileus, CNS
2) Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are
candidates for planned HSCT 3) Class III or IV heart failure (NYHA Class) or LVEF<40%
4) Patients who have GI malabsorption or difficulty taking oral medication 5)
Patients who have psychiatric or congenital disorder 6) Subjects who, in the
investigator's opinion, cannot be treated per protocol due to functional impairments
7) Pregnant or breast-feeding patients; Women of childbearing potential without
adequate contraception (Men must use adequate contraception.) 8) Subjects who have no
intention of following the requirements of the protocol or the follow-up management.
Subjects who cannot be followed up regularly due to psychological, social, family,
logistic, and geographical reasons 9) Subjects who were administered with other
investigational products within 30 days before screening.
10) Subjects who, in the investigator's opinion, cannot be participated.