- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02499224
Safety and Pharmacokinetics Study of YYB101 in Advanced Solid Tumors Patients Who Are Refractory to Standard Therapy
A Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of YYB101, Hepatocyte Growth Factor (HGF)-Neutralizing Humanized Monoclonal Antibody (Mab), in Advanced Solid Tumors Patients Who Are Refractory to Standard Therapy
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients aged 19 years or older
- Patients with pathologically or cytologically confirmed advanced solid tumor which is refractory to standard treatment or for which there is no standard therapy
- ECOG performance status ≤ 2
- Life expectancy of ≥ 12 weeks
Adequate hematologic, hepatic and renal functions as follows:
- ANC ≥ 1,500/µL (without G-CSF support within 2 weeks before IP administration)
- Platelet ≥ 100,000/µL (without transfusion within 2 weeks before IP administration)
- Hemoglobin ≥ 10.0 g/dL (without transfusion within 4 weeks before IP administration)
- Serum creatinine ≤ 1.5 mg/dL or eGRF ≥ 60 mL/min/1.73 m2
- AST and ALT ≤ 2.5 x ULN (AST and ALT ≤ 5 x ULN in the presence of liver metastasis or hepatocarcinoma)
- Total bilirubin ≤ 1.5 x ULN (with exception of the case associated with Gilbert's syndrome)
- PT and aPTT ≤ 1.5 x ULN
- UPC < 1.0 (g/g) (requiring if protein ≥ 1 positive (+) in urinalysis)
- Patients who voluntarily give written informed consent
Exclusion Criteria:
- Patients with hematologic malignancies including lymphoma
- Chemo-, radio-chemo-, biologic-, immuno- or radiotherapy for advanced solid tumor within 4 weeks (or nitrosoureas, mitomycin within 6 weeks or targeted biological antibody within 8 weeks) before IP administration
- Patients had received high-dose chemotherapy requiring hematopoietic progenitor cell support within 2 years before IP administration
- Patients with symptomatic central nervous system (CNS) metastasis (patients who are radiologically and neurologically stable condition for ≥ 4 weeks and discontinued corticosteroids at least 4 week before IP administration are able to participate in this trial.)
- History of deep vein thrombosis or pulmonary embolism within 1 year; Cytomegalovirus (CMV), Epstein-Barr virus (EBV), acute coronary syndrome (including unstable angina or myocardial infarction), or clinically significant cerebrovascular disease (including stroke) within 6 month; Major surgery requiring general anesthesia or respiratory assist within 4 weeks (or video-assisted thoracoscopic surgery or open-and-closed surgery within 2 weeks) before IP administration
- Concurrent NYHA class III or IV heart failure, uncontrolled hypertension, poorly controlled arrhythmia, other clinically significant cardiovascular abnormalities at investigator's discretion (e.g. LVEF < 50%, clinical significant abnormalities of heart wall, or cardiac muscle damage), known positive result for HIV or other uncontrolled active infection disease
- Requirement for continuous non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids
- Receiving anticoagulant, history of bleeding diathesis, massive hemoptysis, gastrointestinal hemorrhage, or peptic ulcer disease (< 325 mg aspirin is acceptable)
- History of severe drug hypersensitivity or hypersensitivity to IP or similar Mab
- Pregnancy or breast-feeding
- Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment
- Patients who received investigational product or investigational device in other clinical trials within 3weeks prior to participation in this trial
- Patients who cannot participate in this trial at the investigator's discretion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: YYB101
Dose-escalation cohort: YYB101 of each dose level (0.3mg/kg to 5mg/kg), IV infusion on Day 1, Day 29, and followed by every 2 weeks Dose-expansion cohort: YYB101 of MTD (or RP2D), IV infusion every 2 weeks
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Dose-escalation cohort: YYB101 of each dose level (0.3mg/kg to 5mg/kg), IV infusion on Day 1, Day 29, and followed by every 2 weeks until disease progression or unacceptable toxicity development. Dose-expansion cohort: YYB101 of MTD (or RP2D), IV infusion every 2 weeks until disease progression or unacceptable toxicity development |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose-escalation cohort: DLTs and MTD
Time Frame: 28 days
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28 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of AEs that result in discontinuation and dose reduction of YYB101
Time Frame: By 12 months after enrollment of the last subject
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By 12 months after enrollment of the last subject
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Clinical laboratory abnormalities that result in discontinuation and dose reduction of YYB101
Time Frame: By 12 months after enrollment of the last subject
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By 12 months after enrollment of the last subject
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Vital sign that result in discontinuation and dose reduction of YYB101
Time Frame: By 12 months after enrollment of the last subject
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By 12 months after enrollment of the last subject
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Anti-YYB101 antibody that result in discontinuation and dose reduction of YYB101
Time Frame: By 12 months after enrollment of the last subject
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By 12 months after enrollment of the last subject
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Area under the plasma concentration versus time curve (AUC) of YYB101
Time Frame: By 4 and 8 weeks after last administration, average 16 weeks
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By 4 and 8 weeks after last administration, average 16 weeks
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Peak Plasma Concentration (Cmax) of YYB101
Time Frame: By 4 and 8 weeks after last administration, average 16 weeks
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By 4 and 8 weeks after last administration, average 16 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum HGF Concentration profile according to YYB101 dosing
Time Frame: By 12 months after enrollment of the last subject
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By 12 months after enrollment of the last subject
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Tissue cMET expression level before YYB101 dosing
Time Frame: By 12 months after enrollment of the last subject
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Tissue cMET expression level and efficacy (Best overall response, Progress-free survival, Disease control rate)
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By 12 months after enrollment of the last subject
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kim Jung Yong, MD, Ph.D, National OncoVenture/National Cancer Center
- Study Director: Hong SungHee, MS, National OncoVenture/National Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOV110501-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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