Nctid:
NCT06613009
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000008175", "term"=>"Lung Neoplasms"}, {"id"=>"D000055752", "term"=>"Small Cell Lung Carcinoma"}, {"id"=>"D000018278", "term"=>"Carcinoma, Neuroendocrine"}], "ancestors"=>[{"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D000013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D000001984", "term"=>"Bronchial Neoplasms"}, {"id"=>"D000018358", "term"=>"Neuroendocrine Tumors"}, {"id"=>"D000017599", "term"=>"Neuroectodermal Tumors"}, {"id"=>"D000009373", "term"=>"Neoplasms, Germ Cell and Embryonal"}, {"id"=>"D000000230", "term"=>"Adenocarcinoma"}, {"id"=>"D000009380", "term"=>"Neoplasms, Nerve Tissue"}], "browseLeaves"=>[{"id"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "asFound"=>"Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M28323", "name"=>"Small Cell Lung Carcinoma", "asFound"=>"Small Cell Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M20423", "name"=>"Carcinoma, Neuroendocrine", "asFound"=>"Neuroendocrine Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "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"}, {"id"=>"M5540", "name"=>"Carcinoma, Bronchogenic", "relevance"=>"LOW"}, {"id"=>"M5260", "name"=>"Bronchial Neoplasms", "relevance"=>"LOW"}, {"id"=>"M20495", "name"=>"Neuroendocrine Tumors", "relevance"=>"LOW"}, {"id"=>"M19845", "name"=>"Neuroectodermal Tumors", "relevance"=>"LOW"}, {"id"=>"M20388", "name"=>"Neuroectodermal Tumors, Primitive", "relevance"=>"LOW"}, {"id"=>"M12318", "name"=>"Neoplasms, Germ Cell and Embryonal", "relevance"=>"LOW"}, {"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M12325", "name"=>"Neoplasms, Nerve Tissue", "relevance"=>"LOW"}, {"id"=>"T5271", "name"=>"Small Cell Lung Cancer", "asFound"=>"Small Cell Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"T4091", "name"=>"Neuroendocrine Tumor", "relevance"=>"LOW"}, {"id"=>"T4092", "name"=>"Neuroepithelioma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4230", "name"=>"Antibodies, Monoclonal", "relevance"=>"LOW"}, {"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M5426", "name"=>"Camptothecin", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SEQUENTIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>198}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-08-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-22", "studyFirstSubmitDate"=>"2024-09-22", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-08-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Numbers of subjects with adverse events", "timeFrame"=>"Up to 3 years", "description"=>"defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed"}, {"measure"=>"Number of subjects with clinically significant changes in physical examination results", "timeFrame"=>"Up to 3 years", "description"=>"Clinically significant abnormal physical examination findings reported by the investigator."}, {"measure"=>"Number of subjects with clinically significant changes in electrocardiogram", "timeFrame"=>"Up to 3 years", "description"=>"Clinically significant abnormal electrocardiogram findings reported by the investigator."}, {"measure"=>"Number of subjects with clinically significant changes in vital signs", "timeFrame"=>"Up to 3 years", "description"=>"Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure"}, {"measure"=>"Dose limiting toxicities (DLTs)", "timeFrame"=>"Up to 29 days", "description"=>"Dose limiting toxicities (DLTs) to establish MTD and/or RP2D."}], "secondaryOutcomes"=>[{"measure"=>"area under the curve (AUC)", "timeFrame"=>"Up to 3 years", "description"=>"area under the curve (AUC) of single and multiple doses of IBI3009"}, {"measure"=>"maximum concentration (Cmax)", "timeFrame"=>"Up to 3 years", "description"=>"maximum concentration (Cmax) of single and multiple doses of IBI3009"}, {"measure"=>"time to maximum concentration (Tmax)", "timeFrame"=>"Up to 3 years", "description"=>"time to maximum concentration (Tmax) of single and multiple doses of IBI3009"}, {"measure"=>"clearance (CL)", "timeFrame"=>"Up to 3 years", "description"=>"clearance (CL) of single and multiple doses of IBI3009"}, {"measure"=>"apparent volume of distribution (V)", "timeFrame"=>"Up to 3 years", "description"=>"apparent volume of distribution (V) of single and multiple doses of IBI3009"}, {"measure"=>"half-life (t1/2)", "timeFrame"=>"Up to 3 years", "description"=>"half-life (t1/2) of IBI3009 to the last administration of IBI3009"}, {"measure"=>"anti-drug antibody (ADA)", "timeFrame"=>"Up to 3 years", "description"=>"Incidence and characterization of anti-drug antibody (ADA)."}, {"measure"=>"objective response rate (ORR)", "timeFrame"=>"Up to 3 years", "description"=>"objective response rate (ORR) as evaluated per the RECIST v1.1 criteria."}, {"measure"=>"duration of response (DoR)", "timeFrame"=>"Up to 3 years", "description"=>"duration of response (DoR) as evaluated per the RECIST v1.1 criteria."}, {"measure"=>"time to response (TTR)", "timeFrame"=>"Up to 3 years", "description"=>"time to response (TTR) as evaluated per the RECIST v1.1 criteria."}, {"measure"=>"progression free survival (PFS)", "timeFrame"=>"Up to 3 years", "description"=>"as evaluated per the RECIST v1.1 criteria."}, {"measure"=>"overall survival (OS)", "timeFrame"=>"Through out the study (an average of 3 years)", "description"=>"OS is defined as the time from the date of first dose of study drug until the date of death from any cause."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Small Cell Lung Cancer and Other Neuroendocrine Carcinomas"]}, "descriptionModule"=>{"briefSummary"=>"The main purpose of this study is to evaluate the safety and tolerability of IBI3009 and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 Dose (RP2D) of IBI3009."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;\n2. Male or female subjects ≥ 18 years old. For Part 1, age ≥18 years and ≤75 years;\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;\n4. Anticipated life expectancy of ≥ 12 weeks;\n5. Adequate bone marrow and organ function confirmed at screening period;\n6. Histologically or cytologically confirmed unresectable, locally advanced or metastatic small cell lung cancer (SCLC), large cell neuroendocrine lung cancer (lung LCNEC),neuroendocrine prostate cancer (NEPC), and other extra-pulmonary neuroendocrine carcinomas;\n\nExclusion Criteria\n\n1. Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;\n2. . Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator's discretion) or baseline prior to the first dose of the study drug;\n3. Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients;\n4. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator's discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.;\n5. Women who are pregnant, have positive results in pregnancy test or are lactating;\n6. Not eligible to participate in this study at the discretion of the investigator."}, "identificationModule"=>{"nctId"=>"NCT06613009", "briefTitle"=>"Study of IBI3009 in Subjects With Unresectable, Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Carcinomas", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Innovent Biologics (Suzhou) Co. Ltd."}, "officialTitle"=>"A Phase I Multicenter, Open-label Study of IBI3009 in Subjects With Unresectable, Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Carcinomas", "orgStudyIdInfo"=>{"id"=>"CIBI3009A101"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"IBI3009", "interventionNames"=>["Drug: IBI3009"]}], "interventions"=>[{"name"=>"IBI3009", "type"=>"DRUG", "description"=>"Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \\& D code: IBI3009)", "armGroupLabels"=>["IBI3009"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"2145", "city"=>"Westmead", "state"=>"New South Wales", "country"=>"Australia", "contacts"=>[{"name"=>"Pei Ding", "role"=>"CONTACT", "email"=>"pei.ding@health.nsw.gov.au", "phone"=>"0422 050 656"}], "facility"=>"Westmead Hospital", "geoPoint"=>{"lat"=>-33.80383, "lon"=>150.98768}}], "centralContacts"=>[{"name"=>"Lue Shen", "role"=>"CONTACT", "email"=>"lue.shen@innoventbio.com", "phone"=>"+86 18507159591"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Innovent Biologics (Suzhou) Co. Ltd.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
