Clinical trial NCT04262739: MTD, Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: solid tumors
failed approved standard therapies
advanced solid tumors
Lead sponsor: Haim Bio Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-10
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety assessment: Adverse event
timeFrame: Up to 2 years
measure: Effectiveness assessment: Disease control rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Pharmacokinetic (PK) Parameter: Cmax of NYH817G and NYH100P
timeFrame: At the start and end of Cycle 1 (each cycle is 21 days)
Other outcomes:
measure: Metabolite change-related: ALDH (for Part 2)
timeFrame: At the start and end of Cycle 1 (each cycle is 21 days)
measure: Metabolism imaging marker-related (for Part 2)
timeFrame: At the start and end of Cycle 1 (each cycle is 21 days)
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Div. of Medical Oncology. Yonsei Cancer Center.
name: Minkyu Jung., MD.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: