MTD, Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Registration Number
- NCT04262739
- Lead Sponsor
- Haim Bio Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description NYH817G and NYH100P NYH817G and NYH100P - NYH100P NYH100P - NYH817G NYH817G -
- Primary Outcome Measures
Name Time Method Safety assessment: Adverse event Up to 2 years Number of adverse events as assessed by NCI CTCAE v5.0
Effectiveness assessment: Disease control rate Up to 2 years To assess the clinical efficacy associated wtih the administration of NYH817G and NYH100P according to the RECIST v1.1
- Secondary Outcome Measures
Name Time Method Pharmacokinetic (PK) Parameter: Cmax of NYH817G and NYH100P At the start and end of Cycle 1 (each cycle is 21 days) Cmax is defined as the maximum observed concentration of each drug
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Korea, Republic of