- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Seoul, Korea, Republikken, 135-710
- Samsung Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Dose-escalation cohort: DLTs and MTD
Tidsramme: 28 days
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28 days
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Incidence of AEs that result in discontinuation and dose reduction of YYB101
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Serum HGF Concentration profile according to YYB101 dosing
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Kim Jung Yong, MD, Ph.D, National OncoVenture/National Cancer Center
- Studieleder: Hong SungHee, MS, National OncoVenture/National Cancer Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NOV110501-101
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Impact Therapeutics, Inc.RekrutteringSolid tumor | Avanceret solid tumorKina, Taiwan, Forenede Stater, Australien
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Partner Therapeutics, Inc.Trukket tilbageSolid tumor | Solid tumor, voksenForenede Stater
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BeiGeneRekrutteringSolid tumor | Avanceret solid tumorForenede Stater, New Zealand, Australien, Kina
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Anjali PawarRekrutteringSolid tumor | Solid tumor, barndomForenede Stater
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Pyxis Oncology, IncRekrutteringSolid tumor | Avanceret solid tumorForenede Stater, Spanien, Belgien
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Neurogene Inc.Merck Sharp & Dohme LLCAktiv, ikke rekrutterendeSolid tumor | Avanceret solid tumorForenede Stater, Australien, Canada
Kliniske forsøg med YYB101
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CellabMEDYooyoung Pharmaceutical Co., Ltd.AfsluttetKolorektal cancer metastatisk | Kolorektal cancer tilbagevendendeKorea, Republikken
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University of WaterlooAdvanced Vision ResearchAfsluttetSyndromer med tørre øjneCanada