Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573

Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573 in Solid Tumors

The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573.

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.

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.