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

Open-label, Phase I Clinical Trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors Who Have Failed Approved Standard Therapies

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 Overview

• Status: Unknown
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: NYH817G; Drug: NYH100P; Drug: NYH817G and NYH100P

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Minghua Huang; Phone Number: +82-2-577-1373; Email: haim@haimbio.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NYH817G	Drug: NYH817G; Subject will orally administer NYH817G (15 mg) during the cycles(21 days)
Experimental: NYH100P	Drug: NYH100P; Subject will orally administer NYH100P (100 mg) during the cycles(21 days)
Experimental: NYH817G and NYH100P	Drug: NYH817G and NYH100P; Subject will orally administer NYH817G (15 mg) and NYH100P (100 mg) during the cycles(21 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment: Adverse event	Number of adverse events as assessed by NCI CTCAE v5.0	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	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) Parameter: Cmax of NYH817G and NYH100P	Cmax is defined as the maximum observed concentration of each drug	At the start and end of Cycle 1 (each cycle is 21 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolite change-related: ALDH (for Part 2)	To evaluate activity of metabolism in tumor tissues	At the start and end of Cycle 1 (each cycle is 21 days)
Metabolism imaging marker-related (for Part 2)	FDG PET-CT (Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography)	At the start and end of Cycle 1 (each cycle is 21 days)

Collaborators and Investigators

• Sponsor: Haim Bio Co., Ltd.
• Investigators: Principal Investigator: Minkyu Jung., MD.,Ph.D., Div. of Medical Oncology. Yonsei Cancer Center.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: advanced solid tumors; solid tumors; failed approved standard therapies
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HBCR-GP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No