Nctid:
NCT06233292
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009369", "term"=>"Neoplasms"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1", "PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SEQUENTIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>484}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2022-06-17", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2026-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-06-13", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-14", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Dose Limiting Toxicities (DLT)", "timeFrame"=>"Up to 21Days", "description"=>"A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause."}, {"measure"=>"Adverse Event (AE)", "timeFrame"=>"Up to 24 Months", "description"=>"Number of participants with adverse events that are related to treatment"}, {"measure"=>"Objective Response Rate", "timeFrame"=>"Up to 24 Months", "description"=>"Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)"}, {"measure"=>"Maximum tolerated dose (MTD)", "timeFrame"=>"Up to 24 Months", "description"=>"During the dose escalation stage, if 2 of up to 6 subjects in the first dose groups experienced DLT, then the dose level will be considered to be an intolerable dose or DLT dose level, and the previous lower dose will be considered to be the MTD."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Solid Tumors"]}, "descriptionModule"=>{"briefSummary"=>"This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Male or female 18-70 years of age;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n* Life expectancy ≥ 3 months;\n* Histologically or cytologically confirmed diagnosis of advanced solid tumors.\n\nExclusion Criteria:\n\n* Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;\n* Any other malignancy within 5 years."}, "identificationModule"=>{"nctId"=>"NCT06233292", "briefTitle"=>"A Study of ZG005 in Patients With Advanced Solid Tumors", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Suzhou Zelgen Biopharmaceuticals Co.,Ltd"}, "officialTitle"=>"A Phase 1/2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors", "orgStudyIdInfo"=>{"id"=>"ZG005-001"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Part 1: Dose Escalation", "description"=>"The study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD).", "interventionNames"=>["Biological: ZG005 Powder for Injection"]}, {"type"=>"EXPERIMENTAL", "label"=>"Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy", "description"=>"The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.Single drug dose expansion was performed in different tumors, such as :Non-small cell lung cancer, small cell lung cancer, Esophageal squamous cell carcinoma, Alveolar soft part sarcoma", "interventionNames"=>["Biological: ZG005 Powder for Injection"]}], "interventions"=>[{"name"=>"ZG005 Powder for Injection", "type"=>"BIOLOGICAL", "otherNames"=>["ZG005"], "description"=>"The dose groups of ZG005 for dose escalations are set as 0.3 mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, and 20mg/kg, intravenous infusion, once every 3 weeks.", "armGroupLabels"=>["Part 1: Dose Escalation"]}, {"name"=>"ZG005 Powder for Injection", "type"=>"BIOLOGICAL", "otherNames"=>["ZG005"], "description"=>"Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy, intravenous infusion, once every 3 weeks.", "armGroupLabels"=>["Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"310022", "city"=>"Hangzhou", "state"=>"Zhejiang", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Hanmei Lou", "role"=>"CONTACT", "email"=>"louhm@zjcc.org.cn"}], "facility"=>"Zhejiang Cancer Hospital", "geoPoint"=>{"lat"=>30.29365, "lon"=>120.16142}}], "centralContacts"=>[{"name"=>"Yongsheng Chu", "role"=>"CONTACT", "email"=>"chuys@zelgen.com", "phone"=>"+86-0512-57309965"}], "overallOfficials"=>[{"name"=>"Jason Wu", "role"=>"STUDY_CHAIR", "affiliation"=>"Suzhou Zelgen Biopharmaceuticals Co.,Ltd"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Suzhou Zelgen Biopharmaceuticals Co.,Ltd", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
