MTD, Safety and Efficacy of NYH817G and NYH100P in Monoth... | NCT04262739

NCT04262739

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Intervention Names
NYH817G	Experimental	Drug: NYH817G
NYH100P	Experimental	Drug: NYH100P
NYH817G and NYH100P	Experimental	Drug: NYH817G and NYH100P

Name	Type	Description	Arm Group Labels	Other Names
NYH817G	Drug	Subject will orally administer NYH817G (15 mg) during the cycles(21 days)	NYH817G

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Measure	Description	Time Frame
Metabolite change-related: ALDH (for Part 2)	To evaluate activity of metabolism in tumor tissues	At the start and end of Cycle 1 (each cycle is 21 days)
Metabolism imaging marker-related (for Part 2)

Eligibility Module

Eligibility Criteria

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