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

NCT ID: NCT04262739

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2021-12-31

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NYH817G

Group Type: EXPERIMENTAL

NYH817G

Intervention Type: DRUG

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

NYH100P

Group Type: EXPERIMENTAL

NYH100P

Intervention Type: DRUG

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

NYH817G and NYH100P

Group Type: EXPERIMENTAL

NYH817G and NYH100P

Intervention Type: DRUG

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

Interventions

NYH817G

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

Intervention Type: DRUG

NYH100P

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

Intervention Type: DRUG

NYH817G and NYH100P

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haim Bio Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minkyu Jung., MD.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Div. of Medical Oncology. Yonsei Cancer Center.

Locations

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Minghua Huang

Role: CONTACT

haim@haimbio.com

+82-2-577-1373

Other Identifiers

HBCR-GP-01

Identifier Type: -

Identifier Source: org_study_id