MTD, Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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The objectives of this study are: Part 1: To assess the MTD, safety and efficacy of each NYH817G and NYH100P in monotherapy in patients with advanced solid tumors who have failed approved standard therapies. To assess the PK properties and the preliminary effectiveness of monotherapy of NYH817G and NYH100P. Part 2: To assess the MTD, RP2D, safety and efficacy of NYH817G and NYH100P in combination therapy in patients with advanced solid tumors who have failed approved standard therapies To assess the PK properties, the preliminary effectiveness and the changes in metabolism of combination therapy of NYH817G and NYH100P.

Official Title
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Open-label, Phase I Clinical Trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors Who Have Failed Approved Standard Therapies

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: NYH817G
* Drug: NYH100P
* Drug: NYH817G and NYH100P


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19+ years old Diagnosed with advanced solid tumor histologically/cytologically Patient without standard therapies or who have failed approved standard therapies Those with a disease that is measurable and/or evaluable with the appropriate imaging examination according to RECIST v1.1 ECOG performance status 0 to 2 Patients with the suitable marrow, kidney, liver functions, blood coagulation and glycemic control functions Patients whose Life expectancy is over 12 weeks Patients who signed the agreement to voluntarily participate in this study Exclusion Criteria: Patients who have received a major surgery, radiotherapy, chemotherapy, biologic therapy, targeted therapy, cancer immunotherapy or metabolic therapy within specified weeks counting from the initial administration of the IPs Diagnosed with a malignant tumor other than the relevant disease in the last 5 years from the initial administration of the IPs Toxicity level has not been recovered to CTCAE Grade 1 or lower Has uncontrolled metastasis to the CNS Suspected of having a serious infectious disease, paralysis of intestine, bowel obstruction, interstitial pneumonia or pulmonary fibrosis Had serious GI bleed or a disease that may affect the absorption of the oral drug in the past 4 weeks Considered as having a serious heart disease by the investigator or a serious internal disease Has administered a drug from another study within 4 weeks Has administered live vaccines within 4 weeks Has abused substance or alcohol within 12 weeks Has a serious trauma Has a history or currently has a type 1 or 2 diabetes Has a history of lactic acidosis Has glucose-6-phosphate dehydrogenase deficiency Has HIV or active or an active hepatitis B or C Has a history of psychological condition that could threaten observation of this protocol Has a history of hypersensitive reaction to the main ingredient or component of the IP or biguanide class drugs Being pregnant or a lactating woman, or (+) pregnancy test A female subject of a childbearing age who plans to get pregnant or disagrees to use recommended contraceptions Has not agreed to abstain from alcohol Considered as unsuitable for the study for other reason by the investigator

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NYH817G<br> | Drug: NYH817G<br>* Subject will orally administer NYH817G (15 mg) during the cycles(21 days)<br>|
| Experimental: NYH100P<br> | Drug: NYH100P<br>* Subject will orally administer NYH100P (100 mg) during the cycles(21 days)<br>|
| Experimental: NYH817G and NYH100P<br> | Drug: NYH817G and NYH100P<br>* Subject will orally administer NYH817G (15 mg) and NYH100P (100 mg) during the cycles(21 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment: Adverse event | Number of adverse events as assessed by NCI CTCAE v5.0 | Up to 2 years | 
| Effectiveness assessment: Disease control rate | To assess the clinical efficacy associated wtih the administration of NYH817G and NYH100P according to the RECIST v1.1 | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) Parameter: Cmax of NYH817G and NYH100P | Cmax is defined as the maximum observed concentration of each drug | At the start and end of Cycle 1 (each cycle is 21 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solid tumors, failed approved standard therapies, advanced solid tumors