[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06592638":3,"trial-entities:NCT06592638":155,"trial-summary:NCT06592638":160},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":51,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":93,"locations":96,"central_contacts":146,"overall_officials":152,"references":153,"see_also_links":154},"NCT06592638","ZG006US001","A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer","A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients With Small Cell Lung Cancer","RECRUITING","2027-06","2025-04","2025-08-06","2025-03-31","Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",null,"This is a multi-center, open-label, Phase 1 clinical study of ZG006 in the US for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. During the dose escalation stage, a standard \"3+3\" design will be used to assess the MTD\u002F recommended dose for the subsequent studies.",[18],"Small Cell Lung Cancer",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE1",{"count":25,"type":26},30,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","ZG006","ZG006 will be administered as an intravenous (IV) infusion.",[33],"Dose Escalation",[35,39,42,44,47,49],{"measure":36,"description":37,"timeFrame":38},"The incidence of dose-limiting toxicity (DLT)","An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria","Up to 28 days",{"measure":40,"timeFrame":41},"Maximum Tolerated Dose (MTD) of ZG006","Approximately 2 years",{"measure":43,"timeFrame":41},"Determine the Recommended Phase 2 Dose (RP2D)",{"measure":45,"description":46,"timeFrame":41},"Number of participants with adverse events (AEs)","The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0",{"measure":48,"timeFrame":41},"Number of participants with serious adverse events (SAEs)",{"measure":50,"timeFrame":41},"Incidence of abnormal laboratory results",[52,55,58,60,62,64,66,68],{"measure":53,"description":54,"timeFrame":41},"Objective response rate (ORR)","ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.",{"measure":56,"description":57,"timeFrame":41},"Duration of response (DOR)","DOR is defined as the time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause",{"measure":59,"timeFrame":41},"Disease control rate (DCR)",{"measure":61,"timeFrame":41},"Maximum plasma concentration (Cmax) of ZG006",{"measure":63,"timeFrame":41},"Time to peak concentration (Tmax)",{"measure":65,"timeFrame":41},"AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of ZG006",{"measure":67,"timeFrame":41},"Terminal phase half-life (t1\u002F2) of ZG006",{"measure":69,"timeFrame":41},"Detection of anti-drug antibodies (ADA)","ALL","18 Years","75 Years",false,{"inclusion":75,"exclusion":81,"raw_text":92},[76,77,78,79,80],"Small cell lung cancer (SCLC), who failed or intolerant to available standard treatments;","Tissue sample positive for DLL3 expression;","Life expectancy ≥ 3 months;","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;","Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.",[82,83,84,85,86,87,88,89,90,91],"Patients having received any of the following treatments:","Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry;","Systemic immunosuppressive medications, such as corticosteroid (doses \\> 10 mg\u002Fday prednisone or equivalent dose) within 14 days prior to the study entry;","Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;","Patients received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry;","A history of severe, life-threatening immune-mediated adverse events or infusion-related reactions during previous anti-tumor immunotherapy, including events that led to permanent discontinuation of treatment;","Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B\u002FC, active syphilis, or active human immunodeficiency virus infection);","Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins;","A female who is pregnant or nursing;","Patients were deemed unsuitable for participating in the study by the investigator for any reason.","Inclusion Criteria:\n\n* Small cell lung cancer (SCLC), who failed or intolerant to available standard treatments;\n* Tissue sample positive for DLL3 expression;\n* Life expectancy ≥ 3 months;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n* Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients having received any of the following treatments:\n\n  * Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry;\n  * Systemic immunosuppressive medications, such as corticosteroid (doses \\> 10 mg\u002Fday prednisone or equivalent dose) within 14 days prior to the study entry;\n  * Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;\n* Patients received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry;\n* A history of severe, life-threatening immune-mediated adverse events or infusion-related reactions during previous anti-tumor immunotherapy, including events that led to permanent discontinuation of treatment;\n* Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B\u002FC, active syphilis, or active human immunodeficiency virus infection);\n* Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins;\n* A female who is pregnant or nursing;\n* Patients were deemed unsuitable for participating in the study by the investigator for any reason.",[94,95],"ADULT","OLDER_ADULT",[97,107,115,123,131,138],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"geoPoint":104},"Zelgen Site 105","NOT_YET_RECRUITING","Orange","California","92868","United States",{"lat":105,"lon":106},33.78779,-117.85311,{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":103,"geoPoint":112},"Zelgen Site 102","Plantation","Florida","33322",{"lat":113,"lon":114},26.13421,-80.23184,{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":103,"geoPoint":120},"Zelgen Site 103","Lexington","Kentucky","40536",{"lat":121,"lon":122},37.98869,-84.47772,{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":103,"geoPoint":128},"Zelgen Site 101","Canton","Ohio","44718",{"lat":129,"lon":130},40.79895,-81.37845,{"facility":132,"status":99,"city":133,"state":126,"zip":134,"country":103,"geoPoint":135},"Zelgen Site 104","Cleveland","44106",{"lat":136,"lon":137},41.4995,-81.69541,{"facility":139,"status":99,"city":140,"state":141,"zip":142,"country":103,"geoPoint":143},"Zelgen Site 106","Houston","Texas","77030",{"lat":144,"lon":145},29.76328,-95.36327,[147],{"name":148,"role":149,"phone":150,"email":151},"Zelgen","CONTACT","+86-02158942758","liusc@zelgen.com",[],[],[],{"nct_id":4,"conditions":156,"biomarkers":158},[157],"Lung Small Cell Carcinoma",[159],"DLL3 Gene",{"nct_id":4,"found":161,"summary":162,"prompt_version":172},true,{"design":163,"status":164,"heading":165,"summary":166,"follow_up":167,"word_count":168,"commitments":169,"compensation":170,"drugs_mentioned":171},"This is a Phase 1 study, meaning it's an early stage of testing a new drug. It will include about 30 participants and is \"open-label,\" so both you and your doctors will know you are receiving ZG006.","completed","Phase 1 ZG006 for Small Cell Lung Cancer","This study is testing a new drug called ZG006 for people with small cell lung cancer. ZG006 is given through an IV (into a vein) and works by targeting specific cancer cells and boosting the immune system. You might be able to join if you have small cell lung cancer that hasn't responded to standard treatments, and your tissue sample shows a specific marker called DLL3. The main goals are to find a safe dose of ZG006 and understand any side effects. This study is currently recruiting participants.","The study will track certain effects for up to 28 days and determine the best dose over approximately 2 years.",88,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]