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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haim Bio Co., Ltd.

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