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

Haim Bio

Status and phase: Unknown; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: NYH100P; Drug: NYH817G; Drug: NYH817G and NYH100P

Study type: Interventional

Funder types: Industry

Identifiers

NCT04262739

HBCR-GP-01

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

NYH817G

Experimental group

Treatment:

Drug: NYH817G

NYH100P

Experimental group

Treatment:

Drug: NYH100P

NYH817G and NYH100P

Experimental group

Treatment:

Drug: NYH817G and NYH100P