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

Hanmi Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: HM95573

Study type

Interventional

Funder types

Industry

Identifiers

HM-RAFI-101

Details and patient eligibility

About

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

Full 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.

Enrollment

72 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.