Trial | NCT04262739  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    42
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.
Study Started
Dec 18
2019
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Oct 20
2020

Drug NYH817G

Subject will orally administer NYH817G (15 mg) during the cycles(21 days)

Drug NYH100P

Subject will orally administer NYH100P (100 mg) during the cycles(21 days)

Drug NYH817G and NYH100P [nyh817g, nyh100p]

Subject will orally administer NYH817G (15 mg) and NYH100P (100 mg) during the cycles(21 days)

NYH817G Experimental

NYH100P Experimental

NYH817G and NYH100P Experimental

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
No Results Posted