Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B continuously.

Detailed Description
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Besides the main objective, there are 4 other objectives as follows: To determine dose-limiting toxicity (DLT) of HM781-36B To determine Maximum Tolerated Dose (MTD) of HM781-36B To determine the effect of food on the pharmacokinetics after dosed HM781-36B continuously To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies

Official Title
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Phase Ⅰ Study to Determine the Maximum Tolerated Dose of HM781-36B Continuously Given in Patients With Advanced Solid Tumors and to Assess the Food Effect on Pharmacokinetic Profile

Conditions
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Advanced Solid Malignancies

Intervention / Treatment
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* Drug: HM781-36B tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed advanced solid tumor Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy 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 Aged ≥19 Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2 A life expectancy greater than 12 weeks Adequate bone marrow, renal and liver function. 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 Exclusion Criteria: Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis. Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT Patients who have GI malabsorption or difficulty taking oral medication Patients who have psychiatric or congenital disorder Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HM781-36B<br>HM781-36B | Drug: HM781-36B tablets<br>* Q1X28D/4W for HM781-36B tablets<br>* Other names: HM781-36B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD determination |  | Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HM781-36B