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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Subject will orally administer NYH817G (15 mg) during the cycles(21 days)
Subject will orally administer NYH100P (100 mg) during the cycles(21 days)
Subject will orally administer NYH817G (15 mg) and NYH100P (100 mg) during the cycles(21 days)
Severance Hospital
Seoul, South Korea
RECRUITINGSafety assessment: Adverse event
Number of adverse events as assessed by NCI CTCAE v5.0
Time frame: 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
Time frame: Up to 2 years
Pharmacokinetic (PK) Parameter: Cmax of NYH817G and NYH100P
Cmax is defined as the maximum observed concentration of each drug
Time frame: At the start and end of Cycle 1 (each cycle is 21 days)
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