MTD, Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Safety assessment: Adverse event [Up to 2 years]
Number of adverse events as assessed by NCI CTCAE v5.0
- Effectiveness assessment: Disease control rate [Up to 2 years]
To assess the clinical efficacy associated wtih the administration of NYH817G and NYH100P according to the RECIST v1.1
Secondary Outcome Measures
- Pharmacokinetic (PK) Parameter: Cmax of NYH817G and NYH100P [At the start and end of Cycle 1 (each cycle is 21 days)]
Cmax is defined as the maximum observed concentration of each drug
Other Outcome Measures
- Metabolite change-related: ALDH (for Part 2) [At the start and end of Cycle 1 (each cycle is 21 days)]
To evaluate activity of metabolism in tumor tissues
- Metabolism imaging marker-related (for Part 2) [At the start and end of Cycle 1 (each cycle is 21 days)]
FDG PET-CT (Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Severance Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Haim Bio Co., Ltd.
Investigators
- Principal Investigator: Minkyu Jung., MD.,Ph.D., Div. of Medical Oncology. Yonsei Cancer Center.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HBCR-GP-01