Neoplasms
Conditions
Brief summary
The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573.
Detailed description
Besides the main objective, there are 3 other objectives as follows: * To evaluate the anti-cancer effect of HM95573 in solid tumor patients * To investigate the pharmacokinetic profile of HM95573 after oral administration. * To investigate biomarkers related to the safety and efficacy of HM95573.
Interventions
DRUGHM95573
BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be 20 years of age or older * Subjects who have provided voluntary consent to participate in the study, and signed the written consent document. * Estimated life expectancy of at least 12 weeks * Histologically or cytologically confirmed advanced solid tumor
Exclusion criteria
* Symptomatic or uncontrolled central nervous system metastases * Patients who are unable to take tablets orally or have a clinically significant gastrointestinal disorder, which may interfere with administration, metabolism and absorption of the investigational drug. * Patients who, in the investigator's opinion, are not suitable for the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 |
Secondary
| Measure | Time frame |
|---|---|
| Overall rsponse rate | 6-12 weeks |
Countries
South Korea
Outcome results
None listed