Nctid:
NCT06616766
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002289", "term"=>"Carcinoma, Non-Small-Cell Lung"}], "ancestors"=>[{"id"=>"D000002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D000001984", "term"=>"Bronchial Neoplasms"}, {"id"=>"D000008175", "term"=>"Lung Neoplasms"}, {"id"=>"D000012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D000013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M11172", "name"=>"Lung Neoplasms", "relevance"=>"LOW"}, {"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "asFound"=>"Non-small Cell Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M5540", "name"=>"Carcinoma, Bronchogenic", "relevance"=>"LOW"}, {"id"=>"M5260", "name"=>"Bronchial Neoplasms", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1", "PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SEQUENTIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>161}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-31", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2028-07-29", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-01", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2028-03-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Overall survival(OS)", "timeFrame"=>"Through study completion, approximately 3.5 year", "description"=>"To assess the overall survival of YH42946"}], "primaryOutcomes"=>[{"measure"=>"Treatment Emergent Adverse Events(TEAE)s", "timeFrame"=>"Through study completion, during the first 21 days of DLT evaluation period.", "description"=>"To assess the safety and tolerability of YH42946"}, {"measure"=>"Objective Response Rate (ORR)", "timeFrame"=>"Through dose expansion part completion, approximately 12 months", "description"=>"Anti-tumor activity according to RECIST v1.1"}], "secondaryOutcomes"=>[{"measure"=>"AUClast", "timeFrame"=>"Through study completion, approximately 12 months", "description"=>"To characterize the pharmacokinetics (PK) of YH42946"}, {"measure"=>"AUCinf", "timeFrame"=>"Through study completion, approximately 12 months", "description"=>"To characterize the pharmacokinetics (PK) of YH42946"}, {"measure"=>"Cmax", "timeFrame"=>"Through study completion, approximately 12 months", "description"=>"To characterize the pharmacokinetics (PK) of YH42946"}, {"measure"=>"Tmax", "timeFrame"=>"Through study completion, approximately 12 months", "description"=>"To characterize the pharmacokinetics (PK) of YH42946"}, {"measure"=>"Objective Response Rate (ORR)", "timeFrame"=>"Through study completion, approximately 12 months", "description"=>"To assess the anti-tumor activity according to RECIST v1.1"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["YH42946-101"], "conditions"=>["NSCLC (non-small Cell Lung Cancer)", "Solid Tumor"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions.", "detailedDescription"=>"YH42946 is a novel, orally available tyrosine kinase inhibitor targeting HER2. YH42946 showed potency for diverse HER2 aberrations including HER2 overexpression, amplification, or mutation, as well as EGFR Ex20ins.\n\nThis is a Phase 1/2, open-label, multicenter, first-in-human study of YH42946. The study has 2 parts. The first part is dose escalation part to identify the maximum tolerated dose. The second part is dose expansion part to select 2 doses for RD selection at the first cohort, after then RD will be determined to ensure its efficacy. Several independent cohorts are planned."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* ECOG performance status 0 or 1\n* Estimated life expectancy of at least 3 months\n* Patients who have progressed on or after all available standard therapies or for whom standard treatment is inappropriate\n* Mandatory provision of archived or fresh tumor tissue in quantity sufficient to allow for retrospective confirmation of HER2 or EGFR mutation\n* A patient with a history of brain metastases must have had all lesions treated\n* Adequate organ function defined as all of the following:\n\n * Adequate bone marrow function (within 1 week prior to first administration): Neutrophils≥1.5 x10\\*9 cells/L (Criteria must be met without the use of Granulocyte-Colony Stimulating Factor (G-CSF) within last week prior to testing.); platelet count≥75 x10\\*9 cells/L; Hb ≥9g/dL (Criteria must be met without packed red blood cell (pRBC) transfusion within last week prior to testing.)\n * Adequate hepatic function: Serum bilirubin≤1.5 x upper limit of normal (ULN), and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases (within 1 week prior to first administration)\n * Adequate renal function: Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) \\> 60 mL/min per 1.73 m\\*2 according to the site's calculation method.\n\n\\[Dose Escalation part only\\]\n\n* Histologically or cytologically confirmed diagnosis of advanced, and/or metastatic non-hematologic malignancy\n* Documented HER2 or EGFR mutation (HER2 tyrosine kinase domain mutation or EGFR exon 20 insertion, HER2 amplification or overexpression)\n\n\\[Dose Expansion part only\\]\n\n* Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC HER2 exon 20 insertion (Cohort 1)\n\nExclusion Criteria:\n\n* Patient with symptomatic or progressive brain metastases\n* Known or suspected leptomeningeal disease (LMD)\n* Uncontrolled spinal cord compression\n* History of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks\n* History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\n* Medical, psychiatric, cognitive or other conditions that compromise the patients ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study\n* Any severe concurrent disease or condition (includes active infections, cardiac arrhythmia) that in the judgment of the Investigator would make study participation inappropriate for the patient\n* History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis\n* History of a second primary cancer with the exception of\n\n 1. curatively treated non-melanomatous skin cancer,\n 2. curatively treated cervical or breast carcinoma in situ, or\n 3. other malignancy with no known active disease present and no treatment administered during the last 2 years\n* Infection with human immunodeficiency virus (HIV) or active chronic hepatitis B or hepatitis C\n* Major surgery within 4 weeks prior to the first dose of study treatment"}, "identificationModule"=>{"nctId"=>"NCT06616766", "briefTitle"=>"A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Yuhan Corporation"}, "officialTitle"=>"A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, PK and Anti-tumor Activity of YH42946 in Patients with Locally Advanced or Metastatic Solid Tumors with HER2 Aberration and EGFR Exon 20 Insertion", "orgStudyIdInfo"=>{"id"=>"YH42946-101"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Part 1 and Part 2", "description"=>"Part 1: Dose escalation arm to determine the MTD Part 2: Dose expansion part to select RD. Several independent cohorts are planned.", "interventionNames"=>["Drug: YH42946"]}], "interventions"=>[{"name"=>"YH42946", "type"=>"DRUG", "description"=>"YH42946", "armGroupLabels"=>["Part 1 and Part 2"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"03080", "city"=>"Seoul", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Do-Youn Oh", "role"=>"CONTACT"}], "facility"=>"Seoul National University Hospital", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}, {"zip"=>"120-752", "city"=>"Seoul", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Byoung Chul Cho", "role"=>"CONTACT"}], "facility"=>"Severance Hospital, Yonsei University", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}], "centralContacts"=>[{"name"=>"Clinical Operation Team 1", "role"=>"CONTACT", "email"=>"yh42946-101_co@yuhan.co.kr", "phone"=>"8228280576"}], "overallOfficials"=>[{"name"=>"Jeongmin Kim", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Yuhan Corporation"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "CSR"], "timeFrame"=>"Beginning 1 year and ending 5 years after all trial endpoints were assessed", "ipdSharing"=>"YES", "description"=>"De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to andrew90@yuhan.co.kr\n\nA summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.", "accessCriteria"=>"Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to andrew90@yuhan.co.kr"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yuhan Corporation", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}